BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8764500 · Received July 5, 2019

    Report

    Report Number
    3004753838-2019-051854
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    May 18, 2019
    Report Date
    July 5, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000613
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMITTENT AUDIO OUTPUT AND AN ADVERSE EVENT OCCURRED. THE PATIENT REPORTED THAT HE WAS HOME ALONE AND WOKE UP ON THE BEDROOM FLOOR AROUND 3:00 AM. HIS MUSCLES WERE CONVULSING, AND HE COULD HARDLY MOVE BUT HE MANAGED TO CRAWL TO THE REFRIGERATOR AND DRINK ORANGE JUICE. HE STATED THAT HE KNEW HE WAS IN DIABETIC SHOCK. HE WAS UNABLE TO STAND AND STAYED ON THE KITCHEN FLOOR UNTIL HE FELT HIS SUGAR WAS RISING, THEN WENT BACK TO BED AT AROUND 4:00 AM. HE STATED THE DEVICE NEVER ALARMED FOR LOW GLUCOSE. IN THE MORNING HIS BLOOD GLUCOSE WAS 126 MG/DL AND HE FELT BETTER. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558497 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719 5251122 00386270000613

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other