BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7770057 · Received August 9, 2018

    Report

    Report Number
    3004753838-2018-89590
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 17, 2018
    Report Date
    February 27, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000293
    PMA / PMN Number
    P170031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, A SIGNAL LOSS AND ADVERSE EVENT WERE REPORTED. THE PATIENT STATED THAT THE G6 MOBILE APPLICATION HAD A SIGNAL LOSS AND DURING THAT TIME, THE PATIENT STARTED TO FEEL LIGHT HEADED AND DECIDED TO MEASURE THEIR BLOOD GLUCOSE (BG). THE BG METER SHOWED THAT THE PATIENT WAS IN THE LOW RANGE AT AROUND 3.0MMOL/L, SO THE PATIENT DRANK FRUIT JUICE. AFTER 15 MINUTES, THE PATIENT WAS FULLY RECOVERED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS INDICATED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE POTENTIAL PATIENT MISUSE - THE PATIENT CLOSED THE MOBILE APP. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608636 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NA NA 00386270000293

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other