BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6005710 · Received October 6, 2016

    Report

    Report Number
    3004753838-2016-72490
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    September 17, 2016
    Report Date
    September 17, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 ABDOMEN ON THE (B)(6) 2016. THERE WAS NO REPORT ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THREE SENSORS WERE RETURNED FOR EVALUATION; HOWEVER IT CANNOT BE DETERMINED WHICH IS THE DEVICE AT FAULT. A VISUAL INSPECTION WAS PERFORMED ON SENSOR (SERIAL# (B)(4)/ LOT# 5211761) AND FOUND THAT THE WIRE IS MISSING FROM THE SENSOR POD AND HOUSING PUCK. THE CUSTOMER'S COMPLAINT OF A MISSING/DETACHED SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. A VISUAL INSPECTION WAS PERFORMED ON SENSOR (SERIAL# (B)(4)/ LOT# 5211761) AND FOUND THAT THE WIRE IS MISSING FROM THE SENSOR POD AND HOUSING PUCK. THE CUSTOMER'S COMPLAINT OF A MISSING/DETACHED SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. A VISUAL INSPECTION WAS PERFORMED ON SENSOR (SERIAL# (B)(4)/ LOT# 5211761) AND FOUND THAT THE WIRE IS MISSING FROM THE SENSOR POD AND HOUSING PUCK. THE CUSTOMER'S COMPLAINT OF A MISSING/DETACHED SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658471 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5211761 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR