BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2902018 · Received January 8, 2013

    Report

    Report Number
    2531779-2013-00371
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING ELEVATED BLOOD GLUCOSE LEVELS (NO VALUE PROVIDED) WITH INCREASED THIRST, FREQUENT URINATION, AND FATIGUE. THE PATIENT REPORTED THAT THE PUMP EMITTED A CS 064 ALARM. THE PATIENT REPORTED ATTEMPTED TO MANUALLY PRIME THE TUBING BUT WAS UNABLE TO PRIME THE TUBING. THE PATIENT REPORTED NOT HAVING ANOTHER INSET OR CARTRIDGE TO TRY. THE PATIENT INDICATED USING AN OLD INFUSION SET. THE PATIENT WAS UNSURE IF THE SUPPLIES WERE EXPIRED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO USING OLD SUPPLIES AND NOT HAVING SUPPLIES TO CHANGE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8524 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening