BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 5646690 · Received May 11, 2016

    Report

    Report Number
    2531779-2016-09666
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    April 24, 2015
    Report Date
    April 25, 2016
    Manufacturer
    DEXCOM INC.
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT REQUIRED FOR RETURN TO ANIMAS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS CORPORATION ALLEGING THE PATIENT'S BLOOD GLUCOSE ON (B)(6) 2016 WAS 540 MG/DL. IT WAS REPORTED THE PUMP ALARMED FOR A SENSOR ERROR 1 CODE. DURING TROUBLESHOOTING, IT WAS DETERMINED THE ISSUE WAS ATTRIBUTED TO USE ERRORS: THE PATIENT WAS NOT WAITING 1 HOUR AND RECALIBRATING THE SENSOR AND THE SENSOR POD WAS DISLODGED OR THE TAPE WAS PEELING. THE REPORTER NOTED THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THERE WAS NO INDICATION OR ALLEGATION OF A DEVICE MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE HEALTH ISSUE WAS ATTRIBUTED TO A USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301174 ANIMAS VIBE OYC LZG DEXCOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening