BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6053730 · Received October 25, 2016

    Report

    Report Number
    2531779-2016-29600
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    October 3, 2016
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: CORRECTION TO TYPE OF DEVICE TO OYC.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE REPORTER CONTACTED ANIMAS, ALLEGING A CGM (DEX 012) ISSUE. IT WAS REPORTED THAT THE CONTINUOUS GLUCOSE MONITORING (CGM) READINGS WERE INACCURATE AS COMPARED TO THE FINGERSTICK BLOOD GLUCOSE (BG) VALUES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN THE USER REACTING TO INCORRECT CONTINUOUS GLUCOSE MONITORING DATA WHICH MAY LEAD TO BG EXCURSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707026 ANIMAS VIBE OYC MDS DEXCOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR