BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2056061 · Received April 1, 2011

    Report

    Report Number
    2531779-2011-01985
    Event Type
    Injury
    Date Received
    April 1, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11/001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE INVOLVED WITH THIS COMPLAINT HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ANIMAS HAS PERFORMED TESTING ON CARTRIDGE LOT # B201576 AND THEY 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 REPORTEDLY HAD INSULIN LEAKING FROM HER CARTRIDGES. THE ANIMAS REP NOTED THAT THE LOT B201576 IS PART OF A RECALL. THE PT REPORTEDLY HAD SYMPTOMS OF NAUSEA AND HEADACHE AND HAD ELEVATED BLOOD GLUCOSE LEVELS (250 MG/DL). THERE WERE NO REPORTS OF ANY MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGEDLY DEVELOPED SYMPTOMS WITH ELEVATED BLOOD GLUCOSE LEVELS AS A RESULT OF THE REPORTED CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR1200/1250/2020/OTP B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R