BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6084143 · Received November 7, 2016

    Report

    Report Number
    3004753838-2016-93339
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 18, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    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).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED. REVIEW OF THE DATA LOG CONFIRMED THE REPORTED INACCURACY. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. THE TRANSMITTER WAS RETURNED FOR EVALUATION. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. TRANSMITTER LOG WAS DOWNLOADED DURING BLUETOOTH PAIRING TEST. A GLOBAL TRANSMITTER FUNCTIONAL TEST WAS PERFORMED AND THE TRANSMITTER PASSED. THE REPORTED INACCURACY COULD NOT BE CONFIRMED VIA DEVICE EVALUATION. A ROOT CAUSE COULD NOT BE DETERMINED VIA DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732043 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 5214242 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR