BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12356538 · Received August 23, 2021

    Report

    Report Number
    3004753838-2021-145356
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    July 31, 2021
    Report Date
    October 5, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001627
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COM-2012059-21.

    Additional Manufacturer Narrative · 0

    COM-2012059-21. B5: DESCRIBE EVENT OR PROBLEM ¿ ADDITIONAL. D10: DEVICE AVAILABILITY ¿ ADDITIONAL/DEVICE. H2: ADDITIONAL INFORMATION/DEVICE EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER ¿ ADDITIONAL. H6: EVENT PROBLEM AND EVALUATION CODES ¿ ADDITIONAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND FAILED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252631 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT25042-4 5291122 00386270001627

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR