BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8474748 · Received April 2, 2019

    Report

    Report Number
    3004753838-2019-031008
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 22, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    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). MFR (3004753838-2019-031008) 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 THERE WAS A MISSING SENSOR WIRE. THE SENSOR WAS INSERTED AT THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2019. NO PRODUCT WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE PROBLEM AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268702 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 5251269 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR