BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8156016 · Received December 12, 2018

    Report

    Report Number
    3004753838-2018-153521
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 12, 2018
    Report Date
    November 12, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, AFTER FURTHER REVIEW OF THE COMPLAINT RECORD, IT WAS DETERMINED THAT THE PATIENT DID NOT RECEIVE A TRANSMITTER FAILED ERROR. REPORT WAS SUBMITTED IN ERROR. PLEASE DISREGARD ALL INFORMATION IN MFR 3004753838-2018-153521 AS THIS WILL NOT BE REPORTABLE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2018. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A TRANSMITTER FAILED ERROR WAS NOT CONFIRMED VIA DATA. A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997521 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5237138 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR