BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19507138 · Received June 10, 2024

    Report

    Report Number
    3004753838-2024-138194
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 10, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6: HEALTH EFFECT CLINICAL CODE - DECREASED LEVEL OF CONSCIOUSNESS.

    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) 2024. ON 04/16/2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES. ACCORDING TO THE REPORT, THE PATIENT SAID HIS NURSE CALLED THE AMBULANCE TWICE ON THE SAME DAY, APPROXIMATELY AROUND 04/16/2024. PLEASE SEE SR 240514-016797 FOR THE FIRST EPISODE. THE D ATE RECORDED WAS JUST AN APPROXIMATE SINCE THE PATIENT COULD NO LONGER REMEMBER THE EXACT DATE. THE PATIENT WAS REPORTEDLY IN THE RESTAURANT WITH HIS NURSE AND SUDDENLY LOST CONTROL OF EVERYTHING AND PASSED OUT. WHEN THE NURSE DID A FS, IT WAS AT 35 MG/DL AND THE DEXCOM WAS READING 130 MG/DL. HIS NURSE HAD TO CALL 911 AND PARAMEDICS CAME TO THE RESTAURANT. PARAMEDICS GAVE THE PATIENT GLUCOSE THROUGH IV. AFTER THAT, PATIENT WAS FINE AND HIS FS WAS AT 100 MG/DL. THE EGV AT THAT TIME WAS NOT DOCUMENTED. THE PATIENT WAS STABLE AND FINE AFTER THAT; HOWEVER, HE DID NOT REMOVE THAT SENSOR. IT WAS NOT SPECIFIED NOR CLARIFIED WHETHER ATTEMPTS WERE MADE TO CALIBRATE THE SENSOR. THAT NIGHT, THE DEXCOM WAS STILL GIVING HIM INACCURATE READINGS. IT STILL SHOWED 100 MG/DL OFF. THE PATIENT COULD NOT RECALL THE VALUES. AROUND 2000, THE PATIENT WAS NOT ALERT AND WHEN HIS NURSE DID A FS HE WAS AT 43 MG/DL AND DEXCOM WAS READING 93 MG/DL, THE NURSE GAVE THE PATIENT APPLE JUICE AND HONEY BY SPOON, THEN SHE CALLED THE AMBULANCE AGAIN. PARAMEDICS CAME TO THE PATIENT'S HOUSE. PARAMEDICS DID A FS AND HIS BLOOD SUGAR WENT DOWN TO 35 MG/DL. THE EGV AT THAT TIME WAS NOT DOCUMENTED. PARAMEDICS GAVE THE PATIENT GLUCOSE THROUGH IV. AFTER THAT, PATIENT FS WENT TO AROUND 100 MG/DL. THE EGV AT THAT TIME WAS NOT DOCUMENTED. THE PATIENT REPORTEDLY DECIDED TO FINALLY REMOVED THE SENSOR. THE PATIENT WAS THEN STABLE AND FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C 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
    802412 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other