BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 11103037 · Received December 31, 2020

    Report

    Report Number
    3004753838-2020-167335
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 7, 2020
    Report Date
    March 9, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B5: PRODUCT RETURNED FOR INVESTIGATION; EXTERIOR PHYSICAL VISUAL INSPECTION: PASSED. TEST TRANSMITTER VOLTAGE: FAIL (0V). D9--YES. RETURNED TO MANUFACTURER. H3 --YES. EVALUATION SUMMARY ATTACHED. H6 --10, TESTING OF ACTUAL/SUSPECTED DEVICE.

    Description of Event or Problem · 0

    PRODUCT WAS RETURNED FOR INVESTIGATION. AN EXTERIOR PHYSICAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A TRANSMITTER VOLTAGE TEST WAS PERFORMED AND FAIL AT 0V.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PAIRING FAILURE OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A FAILED TRANSMITTER ERROR. IN ADDITION, TRANSMITTER FAILED ERROR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE REPORTED EVENT OF A PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF A TRANSMITTER FAILED ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566106 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 7275323 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR