BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12367606 · Received August 25, 2021

    Report

    Report Number
    3004753838-2021-146670
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 31, 2021
    Report Date
    October 3, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COM-2012070-21.

    Additional Manufacturer Narrative · 0

    COM-2012070-21.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE MEASUREMENT: PASSED. PAIRING TEST/DOWNLOAD: FAILED. A REVIEW OF THE SHARE LOG WAS PERFORMED, AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS A DEFECTIVE TRANSMITTER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. 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 THE MOBILE DEVICE LOST POWER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262016 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT25042-4 2638

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR