BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9291580 · Received November 7, 2019

    Report

    Report Number
    3004753838-2019-082587
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 12, 2019
    Report Date
    April 2, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR 300475383-2019-082587 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NON-REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. [INSERT PROBABLE CAUSE STATEMENT]. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083797 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 7258045 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR