BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2012917 · Received March 4, 2011

    Report

    Report Number
    2531779-2011-01351
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE CARTRIDGE WAS RETUNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT # B201582 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FORM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PT NOTICED LEAKAGE IN THE CARTRIDGE COMPARTMENT AND INSIDE THE PLUNGER OF THE CARTRIDGE. THE PT STATED THAT THERE WAS CONDENSATION ON THE INSIDE OF THE CARTRIDGE AND THAT INSULIN WAS SEEN DRIPPING OUT OF THE END OF THE PLUNGER. THE FAMILY MEMBER SAID THAT THE PT FILLED A NEW CARTRIDGE FROM THE SAME LOT NUMBER AND DISCOVERED THE CARTRIDGE WAS LEAKING FROM THE BOTTOM OF THE PLUNGER. THE PT CONFIRMED THAT THE PLUNGER WAS STRAIGHT AND NOT COCKED, THE O-RINGS WERE PRESENT, THERE WERE NO VISIBLE CRACKS ALONG THE SIDES OF THE PLUNGER.

    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 B201582

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR