BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6233742 · Received January 9, 2017

    Report

    Report Number
    3004753838-2017-02524
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000279
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION-THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF. PRODUCT CODE PQF IS NOT CURRENTLY AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION-THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF. PRODUCT CODE PQF IS NOT CURRENTLY AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016, THE RECEIVER CEASED TO FUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF RECEIVER CEASED TO FUNCTION COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT 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 WOULD NOT BOOT UP AND CONTINUOUSLY RE-INITIALIZED. THE REPORTED EVENT THAT THE RECEIVER CEASED TO FUNCTION WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15641 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719-BLU 5219670 00386270000279

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR