BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2033789 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01855
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 22, 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
    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. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH LOT# B201851 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 PT REPORTED, HE HAD LEAKING CARTRIDGES FROM A LOT NUMBER THAT WAS HIGHLIGHTED IN A COMMUNICATION FROM ANIMAS. HE STATED THAT HE DID NOT HAVE ANY LEAKING CARTRIDGES FROM THE SHIPMENT HE REC'D RECENTLY; HE DID NOT USE ANY OF THESE CARTRIDGES. THE PT NOTED THAT HIS BLOOD GLUCOSE READINGS REMAINED WITHIN TARGET.

    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 60 YR