BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5810436 · Received July 20, 2016

    Report

    Report Number
    3004753838-2016-82588
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    July 16, 2016
    Report Date
    July 16, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000231
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) DESCRIBE EVENT OR PROBLEM - ADDITIONAL, IF FOLLOW-UP, WHAT TYPE?: ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT THE RECEIVER DISPLAYED ERROR 121 ON (B)(6) 2016. THE PATIENT DID NOT REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER LOG WAS REVIEWED AND NO ERRORS WERE OBSERVED. THE REPORTED EVENT OF AN ERROR ICON DISPLAY WAS NOT CONFIRMED DURING LOG REVIEW. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A SENSOR POD (SERIAL NUMBER (B)(4)/LOT NUMBER 5201543) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS MISSING FROM THE SENSOR POD AND HOUSING PUCK. THE REPORTED EVENT OF A MISSING SENSOR WIRE WAS CONFIRMED; HOWEVER, IT IS UNKNOWN THAT THE RETURNED PRODUCT IS THE COMPLAINT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464536 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS DEXCOM, INC. MT22719 5209660 00386270000231

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR