BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12247634 · Received July 29, 2021

    Report

    Report Number
    3004753838-2021-133537
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 28, 2021
    Report Date
    September 1, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COM-(B)(4). B5: DESCRIBE EVENT OR PROBLEM: CORRECTION; H2: CORRECTION; H10: CORRECTED DATA. 3004753838-2021-133537 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT, AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Description of Event or Problem · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144511 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT25042-4 7288426

    Patients

    Seq Age Sex Outcome Treatment
    1