BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5496987 · Received March 14, 2016

    Report

    Report Number
    3004753838-2016-36537
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    February 12, 2016
    Report Date
    March 6, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 A MISSING SENSOR WIRE THAT OCCURRED ON (B)(6) 2016.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM 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 EVEN OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2016, TO REPORT A MISSING SENSOR WIRE THAT OCCURRED ON (B)(6) 2016.

    Description of Event or Problem · 1

    THE SENSOR WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS MISSING FROM THE SENSOR POD AND SEAL CARRIER. THE REPORTED EVENT OF A MISSING SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER IT IS NOT KNOW WHETHER THE RETURNED ITEM (LOT# 5202987, SERIAL# (B)(4)) IS REPORTED ITEM AT FAULT OF THE CUSTOMERS INITIAL REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154289 T:SLIM G4 SYSTEM OYC OYC DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR