BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CGM

    MDR report key: 11595424 · Received March 30, 2021

    Report

    Report Number
    MW5100413
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 14, 2021
    Report Date
    March 26, 2021
    Manufacturer
    DEXCOM INC
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    I AM CONDUCTING A RESEARCH STUDY AND USING THE DEXCOM G6 CONTINUOUS GLUCOSE MONITOR IN MY STUDY OF PREGNANT WOMEN WITH AND AT RISK FOR GDM. FOUR OF THE PARTICIPANTS IN OUR STUDY EXPERIENCED SENSOR DEPLOYMENT FAILURES (I.E., THE SENSOR DID NOT COME OFF OF THE APPLICATOR AS IT SHOULD HAVE) DURING OUR STUDY VISITS CONDUCTED VIA (B)(6).THIS UNANTICIPATED MALFUNCTION DID NOT HARM OUR PARTICIPANTS, THANKFULLY, BUT WE BELIEVED THE FDA SHOULD KNOW. (B)(4). WE HAVE REPORTED THESE MALFUNCTIONS TO DEXCOM. WE DESCRIBE APPROX MEAN VALUES FOR THESE 4 RESEARCH PARTICIPANTS IN COMPLETING THIS FORM (WEIGHT, ETC.), TO PROTECT THEIR CONFIDENTIALITY. THERAPY START DATE: (B)(6) 2021. THERAPY END DATE: (B)(6) 2021. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490637 DEXCOM G6 CGM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC G6 CGM 5278432
    490638 DEXCOM G6 CGM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC 5278432
    490639 DEXCOM G6 CGM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC 5278432
    490640 DEXCOM G6 CGM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC 5278432
    490641 SENSOR SENSOR, GLUCOSE, INVASIVE MDS DEXCOM INC 5278432
    490642 SENSOR SENSOR, GLUCOSE, INVASIVE MDS DEXCOM INC 5278432
    490643 SENSOR SENSOR, GLUCOSE, INVASIVE MDS DEXCOM INC 5278432
    490644 SENSOR SENSOR, GLUCOSE, INVASIVE MDS DEXCOM INC 5278432

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR