BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 14112554 · Received April 14, 2022

    Report

    Report Number
    3004753838-2022-059032
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 1, 2022
    Report Date
    January 16, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4)

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO WINDOW DAMAGE. PICTURES WERE TAKEN. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. A MANUAL SOUND TEST WAS PERFORMED AND FAILED AS THE AUDIO WAS LOW. FUNCTIONAL TESTS WERE PERFORMED AND PASSED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO FOREIGN OBJECT DAMAGE. PICTURES WERE TAKEN. THE SPEAKER RESISTANCE WAS MEASURED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE FOREIGN OBJECT DAMAGE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION ISSUE OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO WINDOW DAMAGE. RECEIVER CHARGE TEST WAS PERFORMED AND PASSED. RECEIVER BOOT TEST WAS PERFORMED AND PASSED. FUNCTIONAL TEST WAS PERFORMED AND PASSED. INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO FOREIGN OBJECT DAMAGE TO SPEAKER/FOD. SPEAKER MANUAL TEST WAS PERFORMED AND FAILED. SPEAKER RESISTANCE TEST WAS PERFORMED AND PASSED. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED. THE ALLEGATION WAS CONFIRMED FOR AUDIO ISSUE DUE TO DELAYED ALERTS. THE PROBABLE CAUSE WAS RECEIVER DISPATCH ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279005 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT24078 5267366

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male