BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 370760 · Received January 3, 2002

    Report

    Report Number
    1819470-2002-00001
    Event Type
    Other
    Date Received
    January 3, 2002
    Date of Event
    December 8, 2001
    Report Date
    December 10, 2001
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A NON-HEALTHCARE PROFESSIONAL (NHCP) WITH FURTHER INFO FROM A DIABETIC LIASON OFFICER (NURSE), CONCERNS A PT WHO EXPERIENCED HYPERGLYCEMIA REQUIRING HOSPITALIZATION. THE PT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO-UNKNOWN CARTIDGE HOLDER TYPE) TO DELIVER 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN (HUMULIN M3) FOR THE TREATMENT OF DIABETES. THE PT WAS DIAGNOSED WITH DIABETES IN 2001. THE PT WAS NOT TAKING ANY CONCOMITANT MEDICATION. THE PT COMMENCED USING THE PEN INJECTION DEVICE 10 DAYS AGO. TEN DAYS AFTER COMMENCING USE OF THE PEN INJECTION DEVICE TO DELIVER 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN. THE PT EXPERIENCED HYPERGLYCEMIA, WITH BLOOD SUGARS OF 32.2 AND WAS ADMITTED TO HOSPITAL. AT THE TIME OF EXPERIENCING THE HYPERGLYCEMIA, THE PT'S BLOOD SUGARS WERE ALREADY HIGH, AND THE DIABETES TEAM WERE TRYING TO STABILIZE THE PT'S BLOOD SUGARS WITH 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN. THE PT WAS TREATED WITH INTRAVENOUS INSULIN. THE INITIAL RPTR (NHCP) STATED THE PT'S DIABETES NURSE TOLD THE PT'S FAMILY MEMBER TO NOT PRIME THE PEN OR CHANGE THE NEEDLES BEFORE EACH INJECTION. THIS IS NOT CONFIRMED BY DIABETES LIASON OFFICER. THE INITIAL RPTR STATED THE LEADSCREW OF THE PEN WAS BROKEN. THE DIABETES LIASON OFFICER DID NOT BELIEVE THE PT'S EVENT WAS CAUSED BY A PROBLEM WITH THE PEN. THE DIABETES LIASON OFFICER STATED THE NEEDLE OF THE PEN INJECTION DEVICE WAS BENT AND NOT PIERCING THE RUBBER SEPTUM PROPERLY. 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN CONTINUES. THE PT DISCONTINUED USING THE PEN INJECTION DEVICE 10 DAYS LATER AND COMMENCED USING A REPLACEMENT PEN INJECTION DEVICE (HUMAPEN ERGO). THE EVENT OF HYPERGLYCEMIA DISCONTINUED THE NEXT DAY. 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN CONTINUES. AT THE TIME OF REPORTING THE PT HAS FULLY RECOVERED FROM THE EVENT OF HYPERGLYCEMIA. THE DIABETIC LIASON OFFICER DID NOT CONSIDER THE EVENT OF HYPERGLYCEMIA TO BE RELATED TO THE PEN INJECTION DEVICE OR 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN. THE PEN INJECTION DEVICE HAS BEEN DISCARDED. FURTHER INFO RECEIVED FROM DIABETES LIASON OFFICER (NURSE). PEN INJECTION DEVICE NOT RELATED TO PT'S EVENT, REPORTED A USER ERROR. PEN UNAVAILABLE FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND CO. MS8335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization