Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood glucose decreased, Hypoglycaemia, Incorrect product storage, Seizure
Clinical narrative: Upon internal review, significant correction done on 10 Oct 2016 to update case validity (case became valid) and seriousness criteria of event wrong drug administered (event became non serious) and event from hypoglycemia to blood glucose decreased. Initial unsolicited misuse report received from the literature on 27-Sep-2016. This case is linked to 2016SA181196, 2016SA181233, 2016SA181234, 2016SA181235, 2016SA181236, 2016SA181237, 2016SA181238, 2016SA181240, 2016SA181241, 2016SA181242, 2016SA181243, 2016SA181244, 2016SA181245, 2016SA181246, 2016SA181247, 2016SA181248, 2016SA181249, 2016SA181250, 2016SA181251, 2016SA181252, 2016SA181260 (same literature). The following is verbatim from the article: 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 64-year-old female patient who was administered insulin NOS injection (manufacturer: other) (batch number, expiry date, route and site of administration: not reported) instead of receiving a dose of INFLUENZA VACCINE (seasonal trivalent inactivated influenza vaccine) (manufacturer: unknown) on an unspecified date in 2008. Patient had no known history of diabetes mellitus. Patient's other medical history and concomitant medication were not reported. On an unspecified date in 2008, post administration of insulin, the patient experienced weakness and convulsion and hypoglycemia (blood glucose 46 mg/dL). Patient was seen in the emergency department. It was a case of wrong drug administered (unintentional administration of insulin instead of influenza). Other laboratory was not reported. Blood glucose was 46 mg/dL. Corrective treatment was not reported. The outcome of event was unknown. Upon medical review, the case was considered as serious due to important medical event: hypoglycemia and unintentional administration of insulin instead of influenza. List of documents held by sender: none. Addendum: 10 Oct 2016. Upon second medical examination of case at time of internal review the following has been modified in this case: validity (case became valid) and seriousness criteria of event wrong drug administered (event became non serious) and event from hypoglycemia to blood glucose decreased. Sender's Comments: This case corresponds to a poorly documented literature case with mention of unintentional administration of insulin instead of influenza vaccine. The reported events are consistent with the diagnosis of hypoglycemia secondary to accidental insulin administration; however influenza vaccine was not administered in this case.