BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2058868 · Received April 7, 2011

    Report

    Report Number
    2531779-2011-02344
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Report Date
    March 8, 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
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH, THE CARTRIDGE WAS NOT RETURNED, THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DAMPNESS ON THE CARTRIDGE AND THE CARTRIDGE COMPARTMENT LOOKED LIKE IT HAD MOISTURE. IT WAS REPORTED THAT THE BLOOD GLUCOSE WAS GOOD AND HAS NOT HAD ANY OTHER ISSUES WITH AFFECTED CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200/1250/202/OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1