BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9708958 · Received February 13, 2020

    Report

    Report Number
    3004753838-2020-015550
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    January 18, 2020
    Report Date
    March 6, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS AVAILABLE. HE FELT UNSPECIFIED SYMPTOMS AND THEREFORE CHECKED THE CGM VALUE AND A FINGERSTICK VALUE TO COMPARE. THE CGM READING WAS 4.2 MMOL/L AND THE BG WAS 22.3 MMOL/L SO HE THEN HAD TO GIVE HIMSELF INSULIN TO CORRECT THE HIGH BG VALUE, AND FELT FINE SHORTLY AFTER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    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) 2020. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED ALLEGATION FALLS WITHIN THE D 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 INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168476 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 7263884 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 118 YR Other