BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7105061 · Received December 11, 2017

    Report

    Report Number
    3004753838-2017-111872
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 12, 2017
    Report Date
    November 13, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION PLEASE DISREGARD THE INFORMATION IN REPORT NUMBER 3004753838-2017-111872, UPON FURTHER REVIEW IT WAS CLARIFIED THAT THE PATIENT EXPERIENCED THE RECEIVER BEING STUCK ON THE INITIALIZATION SCREEN WHICH IS CLASSIFIED AS NONREPORTABLE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017 THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER INITIALIZING WITHOUT MANUAL RESTART COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885609 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719-1 5224300

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR