Study: NCT03808376

Adverse event: Invasive lobular carcinoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 181 at risk

Adverse event: Post-surgical staphylococcus infection in left breast
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 181 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 181 at risk

Adverse event: hypoglycemic event
Serious: yes
Organ System: Endocrine disorders
Notes: This SAE was not related to the device or procedures.
Frequency: 1 affected / 181 at risk

Adverse event: Chronic behavioral issues
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 181 at risk

Adverse event: Diabetic ketoacidosis event requiring hospitalization
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 181 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 181 at risk

Adverse event: Skin irritation, adhesive patch location (including erythema, pruritus, rash, contact dermatitis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 181 at risk

Adverse event: Skin irritation, not device related (including abrasion, laceration, redness, tear, rash, contact de
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 181 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 181 at risk

Adverse event: Infection (not related)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 181 at risk

Adverse event: Skin atrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 181 at risk

Adverse event: Skin cancer (left forearm, scalp, ear, nose)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 181 at risk

Adverse event: Infection (insertion/removal site, under adhesive patch)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 181 at risk

Adverse event: Contact dermatitis/Rash (drape adhesive, heat related)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 181 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 181 at risk

Adverse event: Erythema, insertion site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 181 at risk

Adverse event: Seroma, removal site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 181 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 181 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 181 at risk

Adverse event: Influenzas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 181 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 181 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 181 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 181 at risk

Adverse event: Chest pain with tachycardia, dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 181 at risk

Adverse event: Lower extremity edema, bilateral
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 181 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 181 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 181 at risk

Adverse event: Abdominal pain/discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 181 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 181 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 181 at risk

Adverse event: Headache (1 w/ dizziness)
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 181 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 181 at risk

Adverse event: Migraine with nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 181 at risk

Adverse event: Arm Numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 181 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 181 at risk

Adverse event: Pain (back, forehead, hand, neck, etc. )
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 181 at risk

Adverse event: Muscle/Connective tissue injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 181 at risk

Adverse event: Bone Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 181 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 181 at risk

Adverse event: Arthritis/Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 181 at risk

Adverse event: Carpal tunnel
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 181 at risk

Adverse event: Trigger finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 181 at risk

Adverse event: Puncture wound, right foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 181 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 181 at risk

Adverse event: HSV flare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 181 at risk

Adverse event: Hyperglycemia/DKA
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 181 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 181 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 181 at risk

Adverse event: Contusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 181 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 181 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 181 at risk

Adverse event: Ecchymosis, IV site
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 181 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Antibiotic allergy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Food/Drink allergy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Dental work/issues
Serious: no
Organ System: General disorders
Frequency: 8 affected / 181 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 181 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 181 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 181 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 181 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 181 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 181 at risk

Adverse event: Ulcerative keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 181 at risk

Adverse event: Lipoplasty, lower extremities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Metabolic surgery
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Thumb tip cut off, right
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Steristrips did not hold, replaced
Serious: no
Organ System: General disorders
Frequency: 1 affected / 181 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Diabetic ketoacidosis event requiring hospitalization
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Skin irritation, adhesive patch location (including erythema, pruritus, rash, contact dermatitis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Skin irritation, not device related (including abrasion, laceration, redness, tear, rash, contact de
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Infection (not related)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Skin cancer (left forearm, scalp, ear, nose)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Infection (insertion/removal site, under adhesive patch)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 43 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Influenzas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 43 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Headache (1 w/ dizziness)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 43 at risk

Adverse event: Muscle/Connective tissue injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Bone Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Arthritis/Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Carpal tunnel
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 43 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 43 at risk

Adverse event: HSV flare
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 43 at risk

Adverse event: Contusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 43 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Dental work/issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 43 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 43 at risk

Adverse event: Lipoplasty, lower extremities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk

Adverse event: Steristrips did not hold, replaced
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk