BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8176623 · Received December 18, 2018

    Report

    Report Number
    3013756811-2018-46644
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 7, 2018
    Report Date
    December 18, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INTERMITTENT INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS 220-234 MG/DL, AND THE METER BG READING WAS 134-265 MG/DL. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014149 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC DEXCOM, INC. 9500-27 5243818 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR