BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 SENSOR

    MDR report key: 19447388 · Received May 31, 2024

    Report

    Report Number
    MW5155667
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Report Date
    May 30, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QJB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE HAD 3 SENSORS. THE FIRST ONE GLUED ITSELF TO MY SWEATER. FIRST DAY I PUT IT ON. THE SECOND ONE I GOT GAVE ERRATIC READINGS. AFTER A CALIBRATION IT KEPT LOSING ITS SIGNAL. THE THIRD ONE QUIT WORKING AFTER 8 DAYS. AS MUCH AS THE THIRD ONE SEEMED TO MOSTLY GIVE FAIRLY ACCURATE READINGS I DID GET A FEW THAT WERE NO WHERE NEAR WHERE THEY SHOULD HAVE BEEN. REFERENCE REPORTS: MW5155666, MW5155668.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 8/7/2024 FOR REPORT MW5155667 TO UPDATE THE PROCODE. PROCODE: QJB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149824 DEXCOM G7 SENSOR ADJUNCT MONITOR, PROTEIN CALORIE MALNUTRITION QJB DEXCOM, INC.
    573324 DEXCOM G7 SENSOR ADJUNCT MONITOR, PROTEIN CALORIE MALNUTRITION QJB DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male