BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2033423 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01849
    Event Type
    Malfunction
    Date Received
    March 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
    AZ, 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, THE PT'S MOTHER, REPORTED THE INSULIN CARTRIDGE WAS LEAKING INTO THE PUMP CARTRIDGE COMPARTMENT AND THERE WERE BUBBLES IN THE TUBING AND CARTRIDGE. THE PT DID NOT HAVE ANY HIGH OR LOW BLOOD GLUCOSE LEVELS OR EXPERIENCE ANY SYMPTOMS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    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