BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 11438608 · Received March 8, 2021

    Report

    Report Number
    3004753838-2021-44528
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 13, 2021
    Report Date
    May 5, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TRANSMITTER FAILED/ERROR/ALERTRECEIVED ALERT OF TRANSMITTER FAILED ERROR, NOT ABLE TO RESTART THE TRANSMITTER. THE TRANSMITTER HAS BEEN USED LESS THAN 3 MONTHS. THE TRANSMITTER WAS FIRST INSERTED INTO A TRANSMITTER HOLDER: 2021-01-27, TRANSMITTER S/N: (B)(4). SALE DATE: 2021-01-15, SB:2021-08-28, PUMP/RECEIVER: 684192.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328184 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT25042 7275322 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 119 YR