BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6754544 · Received July 31, 2017

    Report

    Report Number
    3004753838-2017-63857
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    July 5, 2017
    Report Date
    July 5, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    20386270000273
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS RECEIVED BUT FURTHER INVESTIGATION CANNOT BE PERFORMED TO CONFIRM THE PROBLEM AND DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE REPORT OF THE RECEIVER INITIALIZING WITHOUT MANUAL RESTART COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED DUE TO RECEIVER HAS ALREADY BEEN SCRAPPED BEFORE QA AND RG LAB CREATED THIS (B)(4). ORIGINAL INVESTIGATION WAS DONE ON (B)(6) 2017. 2250471 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534813 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719-BLU 5224933 20386270000273

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR