BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7655262 · Received July 2, 2018

    Report

    Report Number
    3004753838-2018-71666
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 3, 2018
    Report Date
    June 4, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018 THE RECEIVER DISPLAYED ERR HWW . NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE ERROR ICON COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECEIVER DISPLAYED AN ERROR ICON. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. CHARGE AND BOOT TESTING WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND HARDWARE BATTERY ERRORS WERE FOUND WITHIN THE INVESTIGATION WINDOW. THE RECEIVER WAS OPENED AND AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE ALLEGATION WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498306 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719-1 5224351

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR