Sex: M
Vaccine: FLUX
Symptoms: Blood glucose increased, Product storage error, Wrong technique in product usage process
Clinical narrative: pneumonia; leg pain radiating from his back; husband uses Lantus SoloStar and took an extra pen with him and stored it on ice,; blood sugar was 161 today little higher than normal; administration incorrect; Based on additional information received on 02-Jan-2018, the case was upgraded to serious.  This unsolicited case was received on 12-Mar-2014 from the patient's wife.  This case involves a 78 year old male patient who experienced blood sugar was 161 today little higher than normal (blood sugar increased), had pneumonia, leg pain radiating from his back and incorrect product storage after receiving treatment with insulin glargine (Lantus Solostar) administration was incorrect (drug administration error) and INFLUENZA VACCINE.  No relevant concomitant medications and past drugs were reported.  On an unknown date in Mar-2014, the patient commenced treatment with subcutaneous insulin glargine injection, solution at a dose of 9 units daily delivered via Solostar (strength: 100 IU/ml; batch/lot number: 3F1118 and expiry date: 30-Jun-2016) for diabetes mellitus type 2.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  The patient's wife reported that her husband is currently taking Lantus Solostar (10-11 units daily).  The patient's wife reported of a new insulin glargine pen and asks if she should give her husband his third injection with 8 or 9 U this morning. She said his blood sugar was 138 on day 1. It was 140 on day 2 and the consumer ate spaghetti and his blood sugar was 161 today. She now understands that his physician is the only one who should prescribe doses. The wife of the consumer had many stability, storage, transport questions. She did say that she did a safety test and the dose went to zero but it was delayed. She said she knew he did not get last 1 U in the pen to her husband during the first dose. I don't think I pushed hard enough. She said she thought the 10 count was as she gave the dose. She voiced understanding of the count at the completion of the dose. She voiced understanding of the 10 count at the completion of the dose.  Patient's wife reported that her husband only had 10 units left in one of his insulin glargine pens and still needs his other 3 units. She reported that her husband was having higher blood sugar right now because he had been on Prednisone for 3 days and has 3 more days on it. She reported the prednisone was for leg pain (onset date and latency: unknown) radiating from his back reporting he had a bulging disc. She reported he had the bulging disc 5 years ago but it just returned. She reported he was in the hospital for pneumonia (onset date and latency: unknown) recently too. His dose was normally 11 units daily via parenteral route on an unknown date but for a short time is modifying the dose and was instructed not to "go to high" while on the prednisone. She reported right now he is on 13 units daily via parenteral route on an unknown date in Jan-2016 (lot/batch number: 7F4461A and expiry date: 30-Sep-2019; Lot /batch number: 7F4691A, Exp date: 30-APR-2020). Wife reported that her husband did not usually use buttock for injection because it hurt more in buttocks.  On an unknown date (latency period: Unknown) after initiating treatment with insulin glargine it was reported that the patient uses Lantus SoloStar and took an extra pen with him and stored it on ice, stated the car ride was 4 hours or more and the pen did not feel cool to touch. Caller stated they refrigerated the pen and used it. Caller stated the pen has reached its 28 day mark and wanted to know if it's still ok to use. Caller stated she doesn't know exactly how long the pen was at room temperature.  On an unknown date, the patient experienced a non-serious blood sugar was 161 today little higher than normal (blood glucose increased) two days following the administration of INFLUENZA VACCINE.   Upon follow up, the patient's reported that her husband's blood sugars are not being controlled like they were. And his new insulin glargine pen was the only difference. His blood sugars are running high in the 160 - 190's. No discoloration or anything floating in it. The patient's wife stated that her husband did have pneumonia last September and was placed on prednisone for that. The patient's wife stated that she had spoken with the provider's office, representative from the gluco-strip company who stated that they have tested the machine and everything keeps pointing back to the insulin glargine pen.   Action taken: Dose increased Corrective treatment: Not reported for blood sugar increased Outcome: Unknown for blood sugar increased, pneumonia; recovered/ resolved for leg pain; Not applicable for drug maladministration, incorrect product storage   A product technical complaint (PTC) was initiated for batch number: 7F4691A with global PTC number: 1000933384 and conclusion of PTC was no faults detectable. The company stated we received one used Lantus SoloStar with batch 7F4691A/04.2020 and approximately 190 I.U. amount of residual insulin. The mechanical test and the dose delivery test (Gravimetric investigation) had shown that the SoloStar worked properly and met our specification. In accordance to our SOP an analytical investigation of the complaint sample will not be performed regarding the reason of complaint. A check of a retention sample was already done and met our specification. Based on these results, the reason of complaint was not related to the manufacturing. Other influences related to the therapy and/ or interactions with other medications have also to be considered.  Seriousness Criteria: hospitalization or prolongation  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No further relevant information were reported.  Additional information was received on 02-Jan-2018 from the patient's wife: Event of pneumonia and leg pain added; action taken, form updated and additional therapies, lot/batch number added for insulin glargine. Text was amended accordingly.  Additional information was received on 07-Mar-2018 from the patient's wife: Lab test updated, exp date and lot number added for insulin glargine, corrective added for pneumonia and text amended.  Additional information was received on 22-Mar-2018 from the quality department: Conclusion of PTC no faults detectable added for GPTC number: 1000933384. Text amended accordingly.  Additional information regarding an unsolicited valid serious case was received from a non-healthcare professional (Patient s husband) and transmitted to Sanofi on 01-Jul-2019.  The event incorrect product storage was added.  No further information was reported.  Follow up information received on 10-Oct-2019  regarding an unsolicited valid non-serious case received from a consumer.  Suspect influenza vaccine was updated.  Information on the batch number was requested.; Sender's Comments: Follow-up received on 10-Oct-2019 changes the previous medical assessment.   This case involves a 78 year old male patient who experienced blood sugar increased, had pneumonia, leg pain radiating from his back and incorrect product storage after receiving treatment with insulin glargine (Lantus Solostar) administration was incorrect (drug administration error) and INFLUENZA VACCINE. To be noted that pneumonia and leg pain occurred prior administration of INFLUENZA vaccine hence it is considered not related. Lack of information regarding relevant medical history, concurrent conditions, pre-existing infection, personal and lifestyle history, lab tests ruling out other etiology especially infectious precludes comprehensive case assessment. Based upon the reported information, the role of the suspect product cannot be individually assessed.