BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19464674 · Received June 4, 2024

    Report

    Report Number
    3004753838-2024-132734
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    April 10, 2024
    Report Date
    June 4, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DUE HIGH READINGS FROM DEXCOM. THE PATIENT COULDN'T REMEMBER THE ACTUAL READING AT THAT TIME SINCE THE PATIENT ALREADY PASSED OUT. IT WAS NOT SPECIFIED WHETHER A BG WAS CHECKED FOR THE ENTIRE EPISODE. THE WIFE CALLED 911. THE PATIENT WAS PROVIDED AN EKG AND GLUCOSE BAGS AT THE OF EVENT. THE PATIENT WAS ASKED IF WANTED TO GO TO THE HOSPITAL; HOWEVER, THE PATIENT REFUSED. THE PATIENT COULD NOT RECALL RECALL OTHER INFORMATION ABOUT THE EVENT. OF NOTE, A SIMILAR INCIDENT OCCURRED 2 DAYS LATER. PLEASE SEE RELATED COMPLAINT, SR 240509-013856. THE PATIENT WAS FINE AND OK AT THE TIME OF THE REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO 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
    854723 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other