BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8701220 · Received June 14, 2019

    Report

    Report Number
    3004753838-2019-048642
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 14, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000583
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. A RECEIVER CHARGE AND BOOT TEST WAS PERFORMED AND PASSED. FUNCTIONAL TESTING WAS PERFORMED AND PASSED. "SOUND" AND "TRY-IT" TESTING WAS PERFORMED AND PASSED. SOUND TESTING ON THE RECEIVER COMMUNICATION TOOL WAS PERFORMED AND PASSED. THE RECEIVER WAS OPENED FOR AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED, HOWEVER THE LOG WAS NOT REVIEWED DUE TO DATA NOT BEING RELATED TO THE COMPLAINT. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECEIVER HAD LOW 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
    493627 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT24078 5243131 00386270000583

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR