BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 13196985 · Received January 7, 2022

    Report

    Report Number
    3004753838-2022-002827
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    December 10, 2021
    Report Date
    February 8, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001627
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED ON THE TANDEM PUMP. AS THE PATIENT WAS AWARE OF THE SIGNAL LOSS, A BLOOD GLUCOSE (BG) WAS PERFORMED WHICH WAS OVER 500 MG/DL. THE PATIENT HAD TROUBLE FOCUSING AND CONCENTRATING SO HE CALLED A FRIEND TO TAKE HIM TO THE EMERGENCY DEPARTMENT (ED). HE WAS ADMITTED TO THE HOSPITAL, TREATED WITH AN INSULIN DRIP AND OTHER MEDICATIONS, AND RELEASED THE FOLLOWING DAY. THE SENSOR INSERTION SITE AND DATE WERE NOT PROVIDED. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE CHECK WAS PERFORMED AND PASSED. A PAIRING TEST WAS PERFORMED AND PASSED. A REVIEW OF THE BIN FILE WAS PERFORMED AND SIGNAL LOSS WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. 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
    2477658 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT25042-4 5295919 00386270001627

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other| H TANDEM INSULIN PUMP.