Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Blood glucose decreased, Depressed level of consciousness, Incorrect product storage, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from the literature article on 27 September 2016. This case is linked to 2016SA181196, 2016SA181233, 2016SA181234, 2016SA181235, 2016SA181236, 2016SA181237, 2016SA181238, 2016SA181239, 2016SA181240, 2016SA181241, 2016SA181243, 2016SA181244, 2016SA181245, 2016SA181246, 2016SA181247, 2016SA181248, 2016SA181249, 2016SA181250, 2016SA181251, 2016SA181252, 2016SA181260 (same literature). The following is verbatim from the article: Abstract: Introduction there have been isolated case reports of medication product mix-ups involving insulin unintentionally given to patients when the intent was to administer vaccines. Information on how and why these types of errors occur is limited. Objective To describe incidents of unintentional administration of insulin instead of influenza vaccine and identify possible causes for errors. Methods we describe a 2014 investigation of an apparent mix-up where a cluster of five adult patients unintentionally received insulin instead of influenza vaccine. We also searched Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) vaccine and drug safety monitoring databases from January 2005 to April 2015 in order to identify other incidents. We classified cases as either 'highly suggestive' or 'suggestive' of insulin and influenza vaccine mix-ups. Results Investigation of the primary cluster incident revealed deviations from recommended practices for storage, handling, preparation, and administration of drugs and vaccines; the five cases were classified as highly suggestive of insulin and influenza vaccine mix-ups. Our search of CDC and FDA vaccine and drug safety monitoring databases identified an additional two highly suggestive and 15 suggestive cases, for a total of 22 cases (7 highly suggestive and 15 suggestive) during the 10-year study period. Conclusion Insulin and vaccine mix-ups have the potential to cause serious harm to patients, and are preventable with proper training and application of standards. Our investigation indicated that improper storage including inadequate segregation of insulin and influenza vaccine products in clearly labeled containers or bins lack of standardized procedures for confirming the contents of vials, and decreased vigilance in preparation and administration likely contributed to the primary cluster incident. This case involves a 79 years old male patient who was vaccinated with insulin NOS (manufacturer: other) instead of SEASONAL TRIVALENT INACTIVATED INFLUENZA VACCINE (manufacturer: unknown) on an unspecified date in 2007. It was reported that patient had no known history of diabetes. Other medical history and concomitant medications were not reported. On unspecified date, three hours following the insulin injection patient experienced decreased level of consciousness and blood glucose level of about 33 mg/dL. It was also reported that patient was seen either emergency department or doctor's office. It was a case of wrong drug administered. On unspecified date, patient's lab data included blood glucose as 33 mg/dl. On unspecified date, patient was recovered from the events. Upon internal review the case was considered as serious because of important medical event: decreased level of consciousness and blood glucose 33 mg/dL. Documents held by sender: none. Sender's Comments: This case corresponds to a poorly documented literature case with mention of unintentional administration of insulin instead of influenza vaccine. Decreased level of consciousness may occur secondary to reduction in blood glucose. The reported events occurred in context of accidental insulin administration; however influenza vaccine was not administered in this case.