BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 17573866 · Received August 18, 2023

    Report

    Report Number
    3004753838-2023-164465
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    July 21, 2023
    Report Date
    August 18, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT WAS OUT SHOPPING WHEN SUDDENLY SHE COLLAPSED, HAD A SEIZURE AND WAS UNCONSCIOUS FOR ABOUT 3 TO 5 MINUTES. NO CGM NOR BLOOD GLUCOSE READINGS WERE REPORTED FROM THE TIME THE PATIENT LOSS CONSCIOUSNESS, BUT THE PATIENT RECEIVED GLUCOGEL AND JELLYBEANS FROM THE CHEMIST AT THE STORE. AN AMBULANCE WAS CALLED, AND THE PATIENT WAS BROUGHT TO THE HOSPITAL. AT THE HOSPITAL, A FINGERSTICK WAS PERFORMED, AND THE CGM READING WAS 12.0 MMOL/L, AND THE BLOOD GLUCOSE READING WAS 4.0 MMOL/L. NO SPECIFIC TREATMENT WAS REPORTED BUT IS STATED THAT THEY CHECKED HER BLOOD GLUCOSE READING AND DID UNSPECIFIED BLOOD TESTS. ALL THE RESULTS OF THESE TESTS WERE GOOD, AND AFTER BEING IN OBSERVATION FOR 3-4 HOURS THE PATIENT WAS DISCHARGED. AT THE TIME OF THE REPORT, SHE WAS FEELING BETTER AND THE CGM READING WAS 11.0 MMOL/L. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2167679 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other