BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16081287 · Received December 31, 2022

    Report

    Report Number
    3004753838-2022-244892
    Event Type
    Injury
    Date Received
    December 31, 2022
    Date of Event
    November 23, 2022
    Report Date
    December 31, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORTER EMAIL ADDRESS; (B)(6). 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 HUSBAND STATED THE PATIENT WAS TREMBLING WHEN THE CGM WAS DISPLAYING HIGH. THE PATIENT IS USING THE DIABELOOP DBLG1 PUMP AND THE PUMP AUTOMATICALLY ADMINISTERED 8 UNITS OF INSULIN TO CORRECT THE HIGH READING. A BG COMPARISON WAS PERFORMED WHICH WAS 2.4 MMOL/L. AFTERWARDS, THE HUSBAND PREPARED THE GLUCAGEN 1 MG/ML (POWDER AND SOLVENT) AND ADMINISTERED THE INTRAMUSCULAR INJECTION TO THE PATIENT. THE PATIENT WAS DOING FINE AFTER THE GLUCAGEN INJECTION. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2022. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E 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
    2353894 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 5311127

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other INSULIN PUMP.