BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8799053 · Received July 17, 2019

    Report

    Report Number
    3004753838-2019-054177
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 20, 2019
    Report Date
    October 17, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000583
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PRODUCT WAS EVALUATED. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. CHARGE AND BOOT WERE PERFORMED AND PASSED. RECEVIER FUNCTIONAL TESTING WAS PERFORMED AND FAILED DUE TO SPEAKER FAILURE. G5 GLOBAL COMMUNICATION TOOL TONE AT MEDIUM TEST WAS PERFORMED AND FAILED DUE TO FAILED SOUND. MANUAL FUNCTIONAL TESTS "TRY IT" WAS PERFORMED AND FAILED. OPEN RECEIVER CASE FOR INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO DEFECTIVE SPEAKER WITH METALLIC DEBRIS FOD. PICTURES WERE TAKEN. MEASURE THE SPEAKER RESISTANCE WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERRORS RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW AUDIO OUTPUT OCCURRED. 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
    594229 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT24078 5243141 00386270000583

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR