BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5821101 · Received July 25, 2016

    Report

    Report Number
    3004753838-2016-22238
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    June 27, 2016
    Report Date
    June 28, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 06/28/2016 TO REPORT A MISSING SENSOR WIRE THAT OCCURRED ON (B)(6) 2016. THE SENSOR INSERTION WAS AT THE ABDOMEN ON (B)(6) 2016. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A SENSOR (LOT NUMBER 5211746) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS MISSING FROM THE SENSOR POD AND HOUSING PUCK. DUE TO THE MISSING SENSOR WIRE, THE SENSOR WIRE IS CONSIDERED DETACHED. THE REPORTED EVENT OF A MISSING SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS UNKNOWN IF THE RETURNED DEVICE IS THE COMPLAINT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472513 T:SLIM G4 SYSTEM OYC OYC DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR