BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5317198 · Received December 21, 2015

    Report

    Report Number
    3004753838-2015-74283
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    November 26, 2015
    Report Date
    November 26, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000170
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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) 2015 TO REPORT THAT THE RECEIVER DISPLAYED A FIRMWARE ERROR ON (B)(6) 2015. THE PATIENT DID NOT REPORT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A REVIEW OF THE DOWNLOADED RECEIVER LOG CONFIRMED THE REPORTED EVENT OF A FIRMWARE ERROR. A ROOT CAUSE COULD NTO BE DETERMINED. THE DEXCOM G4PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM REV. 11, UNDER SECTION 13.8.2 RECEIVER ERROR CODE NOTES THE FOLLOWING: THIS SCREEN SHOWS AN ERROR CODE THAT MEANS THE RECEIVER MAY NOT BE WORKING PROPERLY. WRITE DOWN THE ERROR CODE AND CONTACT DEXCOM TECHNICAL SUPPORT. CONTINUE TO CHECK YOUR BLOOD GLUCOSE VALUE USING YOUR BLOOD GLUCOSE METER. NO ALERT SOUND OR VIBRATION WILL WARN YOU THAT YOU ARE NO LONGER GETTING SENSOR GLUCOSE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841166 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-BLU 5204948 00386270000170

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR