BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3021526 · Received March 26, 2013

    Report

    Report Number
    2531779-2013-03087
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP WAS ALARMING FOR LOSS OF PRIME AND WHEN THE PUMP WAS REVIEWED AIR BUBBLES WERE SEEN IN THE TUBING. THE REPORTER INDICATED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 425 MG/DL WITH LETHARGY AND THIRST. THE REPORTER WAS ADVISED ON REMOVING THE BUBBLES FROM THE TUBING AND CARTRIDGE AND THE REPORTER WAS ADVISED TO USE A DIFFERENT LOT OF CARTRIDGE TO SEE IF THE LOSS OF PRIME ISSUES RESOLVED. THE REPORTER CONFIRMED BEING ABLE TO PRIME THE PUMP WITHOUT DIFFICULTY. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124706 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening