BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19158706 · Received April 22, 2024

    Report

    Report Number
    3004753838-2024-093920
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    February 25, 2024
    Report Date
    April 22, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003584
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS 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 ARM. ON (B)(6)2024, IT WAS REPORTED THAT THE PATIENT PASSED OUT AND WAS HOSPITALIZED DUE TO INCORRECT READINGS. PER DOCUMENTATION, THE PATIENT COULD NOT RECALL THE EGV AT THE TIME OF THE EVENT, BUT THE BG READING WAS 32 MG/DL. THE PATIENT ALSO COULD NOT RECALL THE MEDICATION THAT WAS GIVEN TO HIM. HE WAS REPORTEDLY TRANSPORTED TO THE HOSPITAL BY THE FIANCE. BEFORE DISCHARGE, THE BG WAS AROUND 212-222 MG/DL AND THE EGV AT THAT TIME WAS NOT DOCUMENTED. THE PATIENT ALSO REPORTEDLY ATE SOME FOOD BUT HE COULD NOT RECALL THE MEDICATION THAT WAS GIVEN TO HIM. AT THE TIME OF THE REPORT 32 DAYS AFTER THE EVENT, THE PATIENT WAS STABLE AND FEELING FINE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695096 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-160 NI 00386270003584

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other| H