BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 14430751 · Received May 18, 2022

    Report

    Report Number
    3004753838-2022-080293
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 17, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    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) 2022. ON (B)(6) 2022, THE PATIENT WOKE UP AROUND 7:00 AM FEELING UNWELL. THE CGM VALUE WAS 5.1 MMOL/L AND THE BG FINGER STICK WAS 2.1 MMOL/L. THE PATIENT GOT UP, FELL OFF THE BED AND HIT HER HEAD AGAINST THE NIGHTSTAND. ALTHOUGH SHE DID NOT LOSE CONSCIOUSNESS, HER HUSBAND CALLED EMERGENCY MEDICAL SERVICES (EMS) AND SHE WAS TRANSPORTED VIA AMBULANCE TO THE HOSPITAL FOR EVALUATION. SHE WAS TREATED FOR A HEADACHE WITH PARACETAMOL (UNKNOWN QUANTITY) AND GIVEN A NECK BRACE. SHE WAS DISCHARGED LATE THE SAME EVENING IN STABLE CONDITION. SHE WAS GIVEN INSTRUCTIONS TO REST AT HOME AND CONTACT THE HEALTHCARE PERSONNEL (HCP) IF THE HEADACHE PERSISTED. AFTER THE EVENT SHE FELT WELL. HER MEDICAL EQUIPMENT INCLUDES DIABELOOP, AN ACCU-CHEK, AND AN INSIGHT INSULIN PUMP. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C 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
    2606098 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other