BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/OPAQUE

    MDR report key: 386248 · Received March 28, 2002

    Report

    Report Number
    1819470-2002-00011
    Event Type
    Malfunction
    Date Received
    March 28, 2002
    Report Date
    February 4, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE REPORTED BY A NURSE, CONCERNS A PATIENT WHO WAS RECEIVING INSULIN (DETAILS UNKNOWN) VIA A PEN INJECTOR DEVICE (HUMAPEN ERGO). THE DEVICE WAS OPERATED BY THE PATIENT. IT IS UNKNOWN IF THE PATIENT WAS A TRAINED USER. THE AGE OF THE DEVICE IS UNKNOWN. NO MEDICAL HISTORY WAS REPORTED AND IT WAS UNKNOWN IF CONCOMITANT MEDICATIONS WERE GIVEN. IN 2002 IT WAS REPORTED THAT THE PATIENT'S HUMAPEN ERGO (LOT A1480/MODEL MS9511 UPGRADED, A CLEAR CARTRIDGE HOLDER WAS ATTACHED TO THE MS8335 PEN BODY). HAD A MALFUNCTION. THE PEN DID NOT DELIVER THE WHOLE DOSE OF INSULIN, THERE WAS 20 UNITS OF INSULIN STILL INSIDE THE CARTRIDGE. THE INITIAL ANALYSIS INDICATED BROKEN ENGAGEMENT TABS AND THE KNOB WAS BLOCKED. THE PEN WAS RETURNED. NO EVENT WAS ASSOCIATED WITH THIS COMPLAINT. THE PEN WAS SENT TO PDS FOR INVESTIGATION AND KNIFE MARKS WERE FOUND ON THE CARTRIDGE HOLDER TABS. AWAITING FURTHER ANALYSIS BY PDS. PHARMACEUTICAL DELIVERY SYSTEMS PROVIDED DETAILED ANALYSIS RESULTS ON MARCH-2002: PEN EQUIPPED WITH CLEAR CARTRIDGE HOLDER UPGRADE (REF. LOT AC); BOTH ENGAGEMENT TABS DAMAGED - APPEAR TO HAVE BEEN CUT WITH AN UNKNOWN TOOL. NO DAMAGE VISIBLE ON MATING CARTRIDGE HOLDER INTERFACE ENGAGEMENT TAB. ANALYSIS BY PDS FOUND KNIFE MARKS ON THE CARTRIDGE HOLDER TABS. PHARMACEUTICAL DELIVERY SYSTEMS ENTERED RESULTS/CONCLUSIONS AND CORRECTIVE ACTION ON THE SUSPECT DEVICE PAGE, UPDATED THE NARRATIVE AND THE CIOMS-II FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/OPAQUE PEN INJECTOR KZE ELI LILLY AND CO. MS8335 A1480

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO