BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12465046 · Received September 13, 2021

    Report

    Report Number
    3004753838-2021-157783
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 19, 2021
    Report Date
    October 14, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    B. PLEASE CONFIRM IF THE INSTRUMENT WAS USED DURING SURGERY. IF YES, WAS SURGERY TIME EXTENDED? IT WAS USED IN SURGERY SUCCESSFULLY. UNABLE TO DETACH POST OP BY SSD. C. WHAT WAS THE DURATION OF THE DELAY? NO DELAY. D. LOT NUMBER: SIGMA HP SYSTEM HANDLE (202499111). SIGMA HP SYSTEM HANDLE (202499111). I WAS NOT SENT THE LOT NUMBERS I AM AFRAID.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362962 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI TJ2011776

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR