BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 6324276 · Received February 10, 2017

    Report

    Report Number
    3004753838-2017-13361
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 20, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Removal / Correction Number
    3004753838-02/29/16-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    Additional Manufacturer Narrative · 1

    (B)(4). IF FOLLOW-UP, WHAT TYPE?: CORRECTION. ADDITIONAL NARRATIVES/DATA - REMOVE STATEMENT "THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF. PRODUCT CODE PQF IS NOT CURRENTLY AVAILABLE IN COMMON DEVICE NAME." FROM ADDITIONAL MFR NARRATIVE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105980 NI CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR