BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6923765 · Received October 6, 2017

    Report

    Report Number
    3004753838-2017-66455
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 10, 2017
    Report Date
    September 10, 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).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER CEASED TO FUNCTION. 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 REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER CHARGES AND BOOT UP: FAILED - USB PIN(S) FROM J3 ARE DAMAGED. FUNCTIONAL TEST EQ-900302-001: FAILED - CANNOT PERFORM FUNCTIONAL TEST DUE TO RECEIVER COULD NOT BOOT UP AND\OR COMMUNICATE WITH TESTER. THE COMPLAINT WAS CONFIRMED BECAUSE THE DAMAGED USB PIN(S) FROM J3 PREVENTED THE RECEIVER FROM CHARGING THE BATTERY AND THE RX UNIT WILL CEASES TO FUNCTION.THE REPORTED EVENT THAT THE RECEIVER CEASED TO FUNCTION WAS CONFIRMED. THE ROOT CAUSE OF RECEIVER CEASING TO FUNCTION ARE THE DAMAGED USB PIN(S) FROM J3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701911 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719-1 5225183

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR