BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURG/CLEAR

    MDR report key: 591239 · Received April 7, 2005

    Report

    Report Number
    1819470-2005-00008
    Event Type
    Malfunction
    Date Received
    April 7, 2005
    Report Date
    January 16, 2005
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TAKING AN UNSPECIFIED MEDICATION VIA A HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY (LOT 40104) FOR AN UNK INDICATION. IT WAS UNK IF THE PERSON OPERATING THE DEVICE WAS THE PT OR IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE PT REPORTED THAT THE DEVICE WAS NOT WORKING. THIS HUMAPEN ERGO COMPLAINT IS THE DEVICE WAS RETURNED TO THE COMPANY IN 2005. ANS INITIAL ANALYSIS BY THE AFFILIATE QUALITY CONTROL DEPT FOUND: ONE BROKEN ENGAGEMENT TAB. THE REMAINING ENGAGEMENT TAB WAS SEVERELY CRACKED AND DAMAGED AND WAS CONSIDERED BROKEN. THE PRODUCT IS OUT OF SPECIFICATION FOR DOSE ACCURACY. TWO TAB BREAKAGE HAS BEEN SHOWN TO DELIVER AN UNDER DOSE OF INSULIN. THE DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR ADD'L EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURG/CLEAR PEN INJECTOR KZE ELI LILLY AND CO. MS8930 40104

    Patients

    Seq Age Sex Outcome Treatment
    1 *