BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19337347 · Received May 16, 2024

    Report

    Report Number
    3004753838-2024-117168
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 16, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 ARM ON (B)(6) 2024. ON 04/08/2024, IT WAS REPORTED BY EMAIL AND ALSO PHONE CALL TO THE PATIENT THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES. ACCORDING TO THE REPORT, THE PATIENT HAD A HYPOGLYCEMIC EVENT WHILE DRIVING. THE PATIENT STATED THAT HE THOUGHT HIS DEXCOM SYSTEM WAS READING AROUND 60 MG/DL AT THE TIME THE EMTS TOOK HIS BS READING AT 31 MG/DL. IT WAS NOT DOCUMENTED WHETHER THE PATIENT RECEIVED OR ACKNOWLEDGED AN ALERT FOR THE EGV OF 60 MG/DL. OF NOTE, THE PATIENT WAS USING BOTH THE PHONE AND ILET PUMP TO SEE HIS EGVS, BUT REPORTEDLY APPEARED TO HAVE ONLY BEEN USING HIS PUMP TO GET READINGS AT THE TIME OF THE INCIDENT. PATIENT SYMPTOMS AT THE TIME OF THE EVENT WERE NOT DOCUMENTED; HOWEVER, HE WAS DOCUMENTED TO HAVE EXPERIENCED SEVERE HYPOGLYCEMIA. THE PATIENT WAS TREATED BY UNREMEMBERED MEANS AND RECOVERED AND HE REFUSED TO GO TO ER. ACCORDING TO THE REPORT, HE CONTINUED TO WEAR THE WEARABLE AFTER THE INCIDENT, BUT IT FAILED THE NEXT DAY (CAPTURED IN CASE 240419-010282. AT THE TIME OF CONTACT, IT WAS INDICATED THAT THE PATIENT WAS STABLE. 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. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380589 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Other