BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5788203 · Received July 12, 2016

    Report

    Report Number
    3004753838-2016-46066
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    June 14, 2016
    Report Date
    June 15, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2016. SENSOR WAS INSERTED ON (B)(6) 2016. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED ON (B)(6) 2016 AND CONFIRMED THE REPORTED EVENT OF INACCURATE CGM VALUES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ONE USED SENSOR (LOT NUMBER 5202993) WAS RETURNED FOR EVALUATION. THE RETURNED PRODUCT WAS NOT INVESTIGATED AS THE ANALYSIS WOULD NTO BE ABLE TO CONFIRM THE CUSTOMER COMPLAINT. IT IS UNKNOWN IF THE RETURNED DEVICE IS THE COMPLAINT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439171 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR