BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2036479 · Received March 4, 2011

    Report

    Report Number
    2531779-2011-01336
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARTRIDGE LOT # B201581 WAS CONFIRMED TO BE DEFECTIVE AND INSULIN WAS FOUND LEAKING FROM THE PLUNGER SIDE PAST THE FIRST O-RING AND OUT THE HOLE BETWEEN THE TWO O-RINGS. RETURN SAMPLES WERE NOT TESTED FURTHER. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE PT STATED THAT THE CARTRIDGE WAS LEAKING. SHE NOTICED CONDENSATION ON THE PLUNGER WHEN SHE REPLACED THE CARTRIDGE. SHE REPORTEDLY AWOKE WITH A BLOOD GLUCOSE LEVEL OF 300 MG/DL BUT DENIES NAUSEA, VOMITING, OR SHORTNESS OF BREATH. THE SITUATION IS NOT INDICATIVE OF A SERIOUS DIABETIC INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN CARTRIDGE LZG ANIMAS CORPORATION IR 1200 / 1250 / 2020 / OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR