BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22351931 · Received June 27, 2025

    Report

    Report Number
    3004753838-2025-166031
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 27, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    40386270000253
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SENSOR FAILURE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. THE DATE OF THE EVENT IS AN APPROXIMATION. ON (B)(6) 2025, THE PATIENT¿S CGM RECEIVER AND MOBILE DEVICE BOTH ALERTED THAT THE SENSOR HAD FAILED AFTER BEING PLACED ON THE ABDOMEN. AT THE TIME OF THE ALERT, THE PATIENT WAS ASLEEP AND UNCONSCIOUS. HIS WIFE PERFORMED A FINGERSTICK TEST AND FOUND HIS BLOOD GLUCOSE LEVEL TO BE 29 MG/DL. THE COMPLAINT DOES NOT INDICATE WHETHER ANY GLUCOSE ALERTS WERE TRIGGERED PRIOR TO THE SENSOR FAILURE ALERT. THE PATIENT WAS UNCONSCIOUS AND IS UNSURE IF ANY TREATMENT WAS ADMINISTERED AT HOME OR BY EMERGENCY MEDICAL TECHNICIANS (EMT). HE WAS TRANSPORTED TO THE HOSPITAL, BUT HE DOES NOT KNOW WHAT TREATMENT OR MEDICATION WAS PROVIDED DURING HIS STAY. THE PATIENT REMAINED UNCONSCIOUS FOR TWO DAYS FOLLOWING HOSPITAL ADMISSION AND WAS DISCHARGED ON 06/18/20255. AT THE TIME OF THE REPORT, THE PATIENT WAS FINE. PERFORMANCE DATA WAS REVIEWED. A SENSOR FAILURE WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844968 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI 40386270000253

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| O