BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10100867 · Received May 29, 2020

    Report

    Report Number
    3004753838-2020-051395
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 6, 2020
    Report Date
    November 24, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000583
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO THE LCD AND DISPLAY WINDOW BEING DAMAGED. PICTURES WERE TAKEN. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND FAILED THE LCD, DISPLAY PATTERN, ANS SPEAKER TESTS. MANUAL FUNCTIONAL "TRY IT" TESTS WERE PERFORMED AND FAILED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE FOD FOUND ON SPEAKER DIAGRAM. PICTURES WERE TAKEN. THE AUDIO SPEAKER RESISTANCE WAS MEASURED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSED WAS DETERMINED TO BE FOREIGN OBJECT DAMAGED AT THE SPEAKER DIAGRAM. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECEIVER HAD NO AUDIO OUTPUT. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564422 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT24078 5252015 00386270000583

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR