BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9770768 · Received February 28, 2020

    Report

    Report Number
    3004753838-2020-027436
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    February 5, 2020
    Report Date
    February 28, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. DATE OF ISSUE IS AN APPROXIMATION. THE PATIENT STATED THAT HER CGM READINGS WERE 3-4 POINTS LOWER THAN HER BG VALUES ON HER GLUCOMETER. IN ONE INSTANCE HER CGM WAS READING 1.8 MMOL/L SO SHE DRANK SEVERAL APPLE JUICES AND DISCOVERED HER FINGERSTICK BG WAS ACTUALLY 5.8 MG/DL. SHE LATER STATED THAT SHE ALSO TOOK TOO MUCH INSULIN AND HER BG NOT ACTUALLY LOW, BUT IT WAS UNCLEAR WHEN THIS OCCURRED IN RELATION TO THE INACCURATE LOW CGM READING. SHE STATED THAT SHE HAD TO HAVE AN AMBULANCE COME. NO EMERGENCY MEDICAL SERVICES (EMS) TREATMENT INFORMATION WAS PROVIDED BUT SHE STATED THAT THEY TREATED HER AT HOME, SHE DID NOT HAVE TO GO TO THE HOSPITAL, AND SHE WAS FEELING BETTER. AT THE TIME OF CONTACT, THE PATIENT WAS IN STABLE CONDITION. IT WAS INDICATED THAT THE PATIENT EXPOSED COMPONENTS TO MRI, CT SCAN, OR DIATHERMY TREATMENT, WHICH IS OFF-LABEL USAGE OF THE DEVICE. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THIS IS BEING REPORTED DUE TO ADVERSE EVENT AND/OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235514 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other