BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19706671 · Received July 9, 2024

    Report

    Report Number
    3004753838-2024-162862
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 14, 2023
    Report Date
    July 9, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    40386270000253
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. (B)(4) / 240611-016730. DATE OF MEDICAL INTERVENTION (B)(6) 2023. (B)(4) / 240627-015666. DATE OF MEDICAL INTERVENTION (B)(6) 2023. (B)(4) / 240627-015747. DATE OF MEDICAL INTERVENTION (B)(6) 2023 (B)(4) / 240627-015907. DATE OF MEDICAL INTERVENTION (B)(6) 2023. (B)(4) / 240627-015912. DATE OF MEDICAL INTERVENTION (B)(6) 2023. (B)(4) / 240627-015915. DATE OF MEDICAL INTERVENTION (B)(6) 2023.

    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. ON (B)(6) 2024, THE PATIENT REPORTED THAT BEFORE SLEEPING HE DID NOT EXPERIENCE ANY SYMPTOMS OF BEING HYPOGLYCEMIC, HE WAS FEELING NORMAL. THE PATIENT HAS A HISTORY OF HAVING BLOOD GLUCOSE PROBLEMS SINCE HE WAS BORN WITH A PANCREAS DEFECT SO WHEN HIS BROTHER CALLED AND HE WAS NOT ANSWERING THE PHONE, HIS BROTHER WENT TO HIS HOME AND FOUND HIM UNCONSCIOUS AND CALLED 911. NO TREATMENT WAS PROVIDED BY THE BROTHER. WHEN PARAMEDICS ARRIVED THEY PROVIDED HIM WITH SUGAR AND IV FLUIDS. AFTER THE TREATMENT THE PATIENT RECOVERED. ALTHOUGH THE CGM WAS REPORTED INACCURATE, THERE WERE NO CGM NOR BG READINGS PROVIDED AS THE PATIENT COULDN´T REMEMBER. NO OTHER DETAILS WERE DOCUMENTED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270668 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 40386270000253

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other