BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 6239584 · Received January 10, 2017

    Report

    Report Number
    3004753838-2017-01499
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    December 16, 2016
    Report Date
    December 16, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000156
    PMA / PMN Number
    P120005
    Removal / Correction Number
    3004753838-02/29/16-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED INTERMITTENT AUDIO OUTPUT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A RECEIVER (PART NUMBER SR-951300/SERIAL NUMBER (B)(4)/LOT NUMBER 5197918) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. A "TRY IT" MANUAL TEST WAS PERFORMED AND SPEAKER DID NOT SOUND. THE REPORTED EVENT OF AN INTERMITTENT AUDIO OUTPUT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER. HOWEVER, IT IS UNKNOWN IF THE RETURNED PRODUCT IS THE COMPLAINT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21373 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22495 5197918 00386270000156

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR