BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6109647 · Received November 17, 2016

    Report

    Report Number
    3004753838-2016-51731
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    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, TO REPORT A MISSING SENSOR WIRE THAT OCCURRED ON (B)(6) 2016. THE SENSOR INSERTION WAS AT THE ARM ON (B)(6) 2016. THERE WAS NO REPORT ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. IT WAS REPORTED THAT THE SENSOR WAS INSERTED INTO THE ARM. IT SHOULD BE NOTED THAT THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: SENSOR PLACEMENT AND INSERTION IS NOT APPROVED FOR SITES OTHER THAN THE BELLY (ABDOMEN).

    Description of Event or Problem · 1

    A SENSOR (SERIAL NUMBER (B)(4)/LOT NUMBER 5202982) WAS RETURNED FOR EVALUATION A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS ATTACHED TO THE SEAL CARRIER. THE REPORTED EVENT OF A MISSING SENSOR WIRE WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS UNKNOWN IF THE RETURNED PRODUCT IS THE COMPLAINT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760212 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR