BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21044560 · Received December 30, 2024

    Report

    Report Number
    3004753838-2024-340208
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 7, 2024
    Report Date
    February 21, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270002518
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION. D9: DEVICE RETURNED TO MFR - ADDITIONAL INFORMATION. D9: DATE DEVICE RETURNED - ADDITIONAL INFORMATION. H2 TYPE OF FOLLOW UP: ADDITIONAL INFORMATION/ DEVICE EVALUATION. H3: DEVICE EVALUATED BY MFG- ADDITIONAL INFORMATION. H3: EVALUATION INCLUDED - ADDITIONAL INFORMATION. H6: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE 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

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE AND BOOT WAS PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND THE AUDIO TEST FAILED. A MANUAL SOUND TEST WAS PERFORMED AND FAILED. ALARM/ALERT MANUAL TEST WAS PERFORMED AND FAILED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND FOREIGN OBJECT DAMAGE TO SPEAKER/FOD WAS FOUND. PERFORMANCE DATA WAS REVIEWED FINDING ERRORS RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED AS LOW AUDIO OUTPUT VIA PRODUCT. THE PROBABLE CAUSE WAS DETERMINED TO BE FOREIGN OBJECT DAMAGE VIA PRODUCT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820626 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 18038136 00386270002518

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female