BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20698446 · Received November 15, 2024

    Report

    Report Number
    3004753838-2024-300333
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 21, 2024
    Report Date
    November 15, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. H6: HEALTH EFFECT CLINICAL CODE - CHILLS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO AUDIO ALERTS OCCURRED. ON 10/21/2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALERT/NOTIFICATION. THE PATIENT HAD A DENTAL APPOINTMENT AT 2PM. BEFORE GOING TO HER APPOINTMENT, SHE ATE 15 CARBOHYDRATES AND BROUGHT A JUICE WITH HER. AT THIS TIME, HER CGM WAS READING AROUND 180-200 MG/DL. AT 12PM, HER CGM VALUE WAS AROUND 300 MG/DL AND AT 2PM, HER CGM VALUE WAS AROUND 275 MG/DL. NO BG METER COMPARISON VALUES WERE TAKEN DURING THESE TIMES. THE PATIENT WAS WEARING A TANDEM INSULIN PUMP. AT AN UNSPECIFIED TIME LATER, THE PATIENT LOST CONSCIOUSNESS AND WOKE UP ON AN AMBULANCE. IT WAS NOT SPECIFIED HOW LONG THE PATIENT WAS UNCONSCIOUSNESS PRIOR TO WAKING UP. THE PATIENT REPORTED THAT PRIOR TO THIS, SHE DID NOT HEAR HER CGM ALERT TO NOTIFY HER OF HYPOGLYCEMIC STATE (CAPTURED IN THIS COMPLAINT). AT SOME POINT WHILE EMS WAS WITH THE PATIENT, THE PATIENT¿S CGM WAS READING AROUND 70-80 MG/DL (EXACT VALUE WAS NOT KNOWN) AND THE BG METER WAS READING 40 MG/DL (INACCURACY CAPTURED IN SR 241112-009068). THE PATIENT WAS TREATED WITH ORAL GLUCOSE GEL. AFTER TREATMENT, THE PATIENT¿S GLUCOSE LEVEL WENT UP TO 200 MG/DL (IT WAS NOT SPECIFIED WHETHER THIS WAS A CGM OR BG METER READING). EMERGENCY MEDICAL SERVICES ADVISED THE PATIENT TO REMOVE HER SENSOR AND TO PLACE HER INSULIN PUMP IN MANUAL MODE. THERE WAS NO DOCUMENTATION THAT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE PATIENT WAS TIRED AND COLD AT THE TIME OF REPORT. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS UNDETERMINED VIA DATA. HOWEVER, IT WAS FOUND THAT SIGNAL LOSS OCCURRED EQUAL TO OR UNDER ONE HOUR. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307903 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other TANDEM TSLIM PUMP.