BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8754452 · Received July 2, 2019

    Report

    Report Number
    3004753838-2019-51396
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    June 2, 2019
    Report Date
    July 2, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURACIES AND A HYPOGLYCEMIC EVENT. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2019. THE PATIENT DOSED INSULIN BASED ON THE CONTINUOUS GLUCOSE MONITOR (CGM) READING OF 20.5 MMOL/L. HE THEN PERFORMED A BLOOD GLUCOSE (BG) CHECK AND FOUND IT WAS 8.2 MMOL/L. HIS BG RAPIDLY DROPPED TO 1.8 MMOL/L. HE EXHIBITED SYMPTOMS OF SWEATING, FEELING TENSE, AND LACK OF CONCENTRATION. HE DRANK 200 ML OF ORANGE JUICE, ATE 10 (B)(6), AND A CANDY BAR. HIS GLUCOSE LEVEL THEN ROSE TO 6.8 MMOL/L. AT THE TIME OF CONTACT, THE PATIENT WAS FEELING FINE. THE REPORTED ALLEGATION FALLS WITHIN THE C ZONE OF THE PARKES ERROR GRID. DATA WAS PROVIDED FOR INVESTIGATION. THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED POST INVESTIGATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549774 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-46 5251275

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other