BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2042896 · Received March 30, 2011

    Report

    Report Number
    2531779-2011-02087
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Report Date
    February 28, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED BY THE PATIENT THAT SHE HAS HAD AN ISSUE WITH HER CARTRIDGE LEAKING IMMEDIATELY AFTER FILLING. SHE STATED THAT THE CARTRIDGE WOULD LEAK INSULIN AROUND THE PLUNGER PIECE. THE PATIENT REPORTED SHE DID NOT USE ANY OF THE LEAKING CARTRIDGES, THEREFORE, SHE HAD NO BLOOD GLUCOSE EXCURSIONS.

    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