BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2042848 · Received March 30, 2011

    Report

    Report Number
    2531779-2011-02075
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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

    THE PATIENT REPORTED THAT HE HAD A FEW CARTRIDGES THAT LEAKED FROM LOT # B201581. HE STATED THAT HE DID NOT EXPERIENCE ANY BG EXCURSIONS DUE TO THE LEAKING, AND HE DID NOT CALL PREVIOUSLY TO REPORT THE LEAKY CARTRIDGES. THE PATIENT STATED THAT THE PREVIOUSLY USED LEAKING CARTRIDGES ARE NOT AVAILABLE TO BE RETURNED TO ANIMAS.

    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 B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR