BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2012916 · Received March 4, 2011

    Report

    Report Number
    2531779-2011-01354
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # B201583 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    THE PT REPORTED CONDENSATION ON THE INSIDE OF THE USED CARTRIDGES EACH TIME HE REMOVED THEM OVER THE PAST TWO WEEKS. HE SAID THAT ONE TIME, HE NOTICED A POOL OF INSULIN INSIDE THE CARTRIDGE COMPARTMENT. AT THAT TIME, THE PT'S REPORTED BLOOD GLUCOSE WAS 400MG/DL WITHOUT PRESENCE OF SYMPTOMS OF HYPERGLYCEMIA. THIS BLOOD GLUCOSE DESCRIPTION DOES NOT INDICATE A SERIOUS ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGED CARTRIDGE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201583

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR