BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4121434 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27629
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP DEVICE 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 AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 450MG/DL WITH NAUSEA, INCREASED THIRST, KIDNEY PAIN, EXTREME DROWSINESS/DIFFICULTY WAKING UP/CONFUSION. DURING TROUBLESHOOTING, THE REPORTER STATED THAT THERE WAS LEAKING FROM THE LEUR LOCK, BUT WAS UNABLE TO DETERMINE WHETHER IT WAS THE INSET OR CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA AND BECAUSE THE ALLEGED CARTRIDGE LEAK WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602139 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening