BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2032290 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01862
    Event Type
    Injury
    Date Received
    March 23, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. 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 REPORTER, THE PT'S MOTHER, REPORTED THAT THE PAST EIGHT TO TEN WEEKS, THE PT HAD OBTAINED HIGH BLOOD GLUCOSE READINGS FROM 100MG/DL TO 500MG/DL. DURING THIS TIME PERIOD, THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, HAD FREQUENT TRACE URINARY KETONES, AND DID NOT SEEK MEDICAL ATTENTION OR TREATMENT. THE REPORTER NOTED THE INSULIN CARTRIDGE WAS LEAKING INTO THE PUMP'S CARTRIDGE COMPARTMENT, THERE WERE AIR BUBBLES IN THE TUBING AND THE CARTRIDGE COMPARTMENT WAS WET. THE PT'S BLOOD GLUCOSE LEVELS WERE MANAGED WITH BOLUS INSULIN DOSES GIVEN BY SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200 / 1250 / 2020 OTP B201575

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R