BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8646550 · Received May 28, 2019

    Report

    Report Number
    3013756811-2019-27880
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 28, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    10386270000221
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A FAILED TRANSMITTER ERROR. REPORTEDLY, THE TRANSMITTER HAD BEEN IN USE LESS THAN 3 MONTHS. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT TRANSMITTER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441332 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC DEXCOM, INC. 9438-06 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR