BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8996747 · Received September 11, 2019

    Report

    Report Number
    3013756811-2019-56596
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 20, 2019
    Report Date
    September 11, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE TANDEM USER GUIDE, ¿MAKE SURE A SENSOR GLUCOSE READING SHOWS IN THE UPPER RIGHT PORTION OF THE CGM HOME SCREEN BEFORE CALIBRATING.¿ 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 AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS 45-359 MG/DL, AND THE METER BG READING WAS 142-155 MG/DL. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. REPORTEDLY, THE CUSTOMER CALIBRATED WHILE CGM READINGS WERE NOT PRESENT AND. REPORTEDLY, DURING TROUBLESHOOTING THE CUSTOMER PERFORMED A CALIBRATION AND CGM READINGS BECAME ACCURATE. A REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790494 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC DEXCOM, INC. 9500-27 7254166 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR