BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3961803 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21606
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT REPORTED WAS ALSO INCLUDED ON REPORT 2531779-2014-21560. THE PRODUCT 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A BLOOD GLUCOSE OF 28 MMOL/L WITH LIGHTHEADEDNESS AND INCREASED THIRST ASSOCIATED WITH LOSS OF PRIME WARNINGS ON THE PUMP. DURING A REVIEW OF THE EVENT, THE REPORTER INDICATED THAT THE PUMP HAD EMITTED LOSS OF PRIME WARNINGS TWICE; THERE WERE NO SUDDEN CHANGES IN FORCE NOTED, THE PATIENT CONFIRMED PROPER PREPARATION OF THE INSULIN CARTRIDGE, AND THERE WERE NO OTHER REPORTED ALARMS RELATED TO THE LOSS OF PRIME WARNINGS. 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
    439122 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening