BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 17263430 · Received July 5, 2023

    Report

    Report Number
    3004753838-2023-132597
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 7, 2023
    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
    FL, 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). 3004753838-2023-132597 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    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 SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT EXPERIENCED INACCURATE CGM VALUES 2 DAYS AFTER THE SENSOR WAS INSERTED IN THE ABDOMEN. THE PATIENT EXPERIENCED HEADACHE, WEAKNESS, THIRST AND FELT DRY. HE CALLED 911 AND THEY TOOK HIM TO THE HOSPITAL WHERE HE WAS TREATED WITH INSULIN AND IV MEDICATION. THEY PERFORMED SOME TEST AND AN ECHOCARDIOGRAM. THE CGM WAS READING 330 MG/DL AND THE BLOOD GLUCOSE READING WAS 550 MG/DL. THE PATIENT WAS DISCHARGED THE NEXT DAY. AT THE TIME OF THE REPORT, HE WAS DOING OKAY. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B 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.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786522 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9535-45 7324524 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other