BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2027544 · Received March 16, 2011

    Report

    Report Number
    2531779-2011-01701
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 21, 2011
    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
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGES INVOLVED WITH THIS COMPLAINT WERE REQUESTED TO BE RETURNED; HOWEVER, ANIMAS HAS NOT RECEIVED THEM. IF THE CARTRIDGES ARE RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. CARTRIDGES WITH LOT # B201582 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 CONTACTED ANIMAS TO REPORT INSULIN LEAKING FROM 2 CARTRIDGES (LOT B201582). THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PT WAS ADVISED TO DISCONTINUE USING THE REPORTED LOT # OF CARTRIDGES AND REPLACEMENT CARTRIDGES WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG 1200/1250/2020/OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1