BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12683057 · Received October 22, 2021

    Report

    Report Number
    3004753838-2021-224603
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    August 21, 2021
    Report Date
    April 20, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001627
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. EXTERIOR PHYSICAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE CHECK WAS PERFORMED AND PASSED. DEVICE LOG DOWNLOADED: YES. DATA REVIEW COMPLETED BY FFA. DATA REVIEW CONFIRMS ALLEGATION: YES. BIN FILE ANALYSIS: FAILED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND NOTHING RELEVANT WAS FOUND. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    COM-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR 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
    1577124 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT25042-4 5292554 00386270001627

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female