BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2033420 · Received February 23, 2011

    Report

    Report Number
    2531779-2011-01848
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Report Date
    February 22, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201576 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 REPORTED THAT THE INSULIN CARTRIDGE WAS LEAKING INTO THE PUMP'S CARTRIDGE COMPARTMENT. THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, HAD NO HIGH OR LOW BLOOD GLUCOSE LEVELS AND DID NOT SEEK MEDICAL ATTENTION.

    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 B201576

    Patients

    Seq Age Sex Outcome Treatment
    1