BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12450808 · Received September 9, 2021

    Report

    Report Number
    3004753838-2021-155371
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    August 23, 2021
    Report Date
    September 9, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    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) 2021. ON (B)(6) 2021, THE PATIENT DOSED INSULIN BASED ON A CGM READING OF 15.0 MMOL/L. HE PASSED OUT AND HIS WIFE TOOK HIM TO THE HOSPITAL. HIS BG WAS CHECKED THERE WITH A RESULT OF 1.4 MMOL/L. HE WAS GIVEN AN IV DEXTROSE DRIP, AND REPORTED THAT HE WAS RELEASED 20 MINUTES LATER. HIS BG AT THE TIME OF DISCHARGE WAS 6.5 MMOL/L. HE HAD REMOVED THE CGM SENSOR BEFORE GOING TO THE HOSPITAL, SO NO COMPARISON CGM VALUE WAS AVAILABLE AT THAT TIME. AT THE TIME OF THE REPORT HE WAS FEELING NORMAL. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346767 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other