BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9335518 · Received November 18, 2019

    Report

    Report Number
    3004753838-2019-089174
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 20, 2019
    Report Date
    February 18, 2020
    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 · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. DOWNLOAD RX LOG AND PERFORM REVIEW OF THE RX LOG: PATIENT REPORTED A LOSS OF CONNECTION ON (B)(6) 2019 WITH RX UNIT (B)(4) - CUSTOMER COMPLAINT LOSS OF CONNECTION COULD NOT BE VERIFIED IN LOG REVIEW ON THE INCIDENT DAY BECAUSE RX UNIT AND TX UNIT WERE NOT IN A SENSOR SESSION AND\OR PAIRED ON THE INCIDENT DAY. TEST ON RECEIVER FUNCTIONAL TEST STATION: PASSED ALL RELEVANT TESTING. PERFORM PARING\CALIBRATION\PERFORMANCE\RANGE TEST: PASSED. - AFTER PERFORMING THE FFA LAB PARING\CALIBRATION\PERFORMANCE\RANGE TEST WITH THE RX UNIT (B)(4) THAT THE CUSTOMER SENT BACK WITH A GOOD KNOW TX UNIT 40A2EC, FFA LAB COULD NOT FIND ANYTHING WRONG WITH RX UNIT (B)(4) - PLEASE NOTE THAT DURING THE ENTIRE FFA LAB PAIRING\CALIBRATION\PERFORMANCE\RANGE TEST, THE RETURNED (B)(4) UNIT AND THE GOOD KNOWN TX UNIT 40A2EC WERE ~20 FT APART. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131521 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT23620

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR