BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10877121 · Received November 20, 2020

    Report

    Report Number
    3004753838-2020-141376
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 25, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MFR #141376 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NON-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 TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338085 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5272987 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR