BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2926562 · Received January 23, 2013

    Report

    Report Number
    2531779-2013-01056
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    December 30, 2012
    Report Date
    December 30, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 BLOOD GLUCOSE LEVELS UP TO 474 WITH "MILD SYMPTOMS"; THE PATIENT REPORTED KNOWING THAT BLOOD GLUCOSE LEVELS WERE ELEVATED BY CHANGES OF BREATH. THE PATIENT INDICATED THAT AIR BUBBLES WERE NOTED IN THE INFUSION SET TUBING; UPON REMOVING THE CARTRIDGE AIR BUBBLES WERE ALSO NOTED IN THE CARTRIDGE. TROUBLESHOOTING OF THE CARTRIDGE FILLING TECHNIQUES FOUND THAT THE PATIENT WAS NOT CYCLING THE CARTRIDGES, THE PATIENT WAS NOT ALLOWING THE INSULIN TO COME TO ROOM TEMPERATURE, THE PATIENT WAS NOT PROPERLY PRESSURIZING THE INSULIN VIAL PRIOR TO WITHDRAWING INSULIN INTO THE CARTRIDGE, AND THE PATIENT WAS NOT REMOVING AIR BUBBLES FROM THE CARTRIDGE PRIOR TO INSERTING THE CARTRIDGE INTO THE PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO INCORRECT CARTRIDGE FILLING TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31839 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening