BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2050406 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02286
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 5, 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

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH REPORTED LOT # 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 REPORTER CLAIMED THE PT HAD ELEVATED BLOOD GLUCOSE AS HIGH AS 300 MG/DL WHILE USING THE INSULIN CARTRIDGE WITH THE RECALL LOT #B201576. THE PT DID NOT DEVELOP ANY SYMPTOMS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED RECALL LOT # INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200 / 1250 / 2020/ OTP B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR