BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 11392948 · Received March 1, 2021

    Report

    Report Number
    3004753838-2021-40524
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    January 30, 2021
    Report Date
    March 1, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 ARM ON (B)(6) 2021. SEVERAL EXAMPLES WERE A BG OF 33 MG/DL WITH A CGM READING OF 109 MG/DL, A BG OF 80 MG/DL WITH A CGM READING OF 150 MG/DL, AND A BG OF 120 MG/DL WITH A CGM READING OF 180 MG/DL. IN THE INSTANCE WHEN THE BG WAS 33 MG/DL THE PATIENT WAS WEAK AND FELT NAUSEOUS. IT WAS REPORTED THAT ¿THERE WAS STILL CONTACT WITH HIM,¿ PRESUMED TO MEAN HE WAS STILL CONSCIOUS AND ALERT. THE MOTHER GAVE THE SON LIQUID GLUCOSE TO DRINK, ¿1 WW BY MED MED IN SACHETS.¿ SHE DID NOT CALL A DOCTOR. AFTER ABOUT 20 MINUTES THE PATIENT WAS OKAY. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B, C, AND D ZONE OF THE PARKES ERROR GRID. HOWEVER, THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289533 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-44 5279184

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other