BEUDAMED
    FDA Adverse Event Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3002598 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02678
    Date Received
    March 13, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201819; A LEAK TEST WAS PERFORMED WITH NO FAILURES; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS OR ELSEWHERE ON THE CARTRIDGE.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS UP TO 29.6 MMOL/L WITH INCREASED URINATION AND THIRST FOR SEVERAL DAYS. THE REPORTER INDICATED THAT WHEN THE CARTRIDGE WAS REMOVED, THERE WERE AIR BUBBLES IN THE CARTRIDGE. TROUBLESHOOTING OF THE FILLING TECHNIQUE INDICATED THAT THE REPORTER WAS NOT CYCLING THE CARTRIDGE PRIOR TO FILL AND WAS SOMETIMES USING REFRIGERATED INSULIN IN THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO INCORRECT CARTRIDGE FILLING TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105945 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION B201819

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening