BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10326526 · Received July 27, 2020

    Report

    Report Number
    3004753838-2020-077691
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    July 24, 2020
    Report Date
    February 3, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM - CORRECTION. H2: CORRECTION.

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL D10: DEVICE AVAILABLE FOR EVALUATION - ADDITIONAL H2: ADDITIONAL INFORMATION/DEVICE EVALUATION H3: DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL H6: EVENT PROBLEM AND EVALUATION CODES - ADDITIONAL.

    Description of Event or Problem · 0

    AN INTERNAL VISUAL INSPECTION WAS PERFORMED FAILED DUE TO FOREIGN OBJECT DAMAGE ON THE SPEAKER DUST COVER.

    Description of Event or Problem · 0

    THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND FAILED THE SPEAKER TESTS. A "TRY IT" SOUND TEST WAS PERFORMED AND FAILED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED FAILED DUE TO FOD ON SPEAKER DIAPHRAGM. PICTURES WERE TAKEN. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING NO ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE FOREIGN OBJECT DAMAGE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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
    790089 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT24078-1 5264576

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR