BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 9468141 · Received December 13, 2019

    Report

    Report Number
    3013756811-2019-87658
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    November 22, 2019
    Report Date
    December 13, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS 209 MG/DL, AND THE METER BG READING WAS 374 MG/DL. CUSTOMER TESTED BG LEVEL WITH MULTIPLE BG METERS AND BG LEVELS DISPLAYED FLUCTUATED (180-408 MG/DL) OVER A SHORT TIME PERIOD. SUBSEQUENTLY, THE CUSTOMER WAS HOSPITALIZED DUE TO THE REPORTED INACCURACIES AND WITH A BG LEVEL OF 54 MG/DL TO OVER 200 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INSULIN INJECTIONS. AT THE TIME OF THE REPORT WITH TANDEM TECHNICAL SUPPORT THE CUSTOMER WAS STILL ADMITTED TO THE HOSPITAL AND WAS ¿MORE STABLE AND FELT BETTER¿. CUSTOMER WAS SCHEDULED TO BE RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER; HOWEVER, A RESPONSE WAS NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260847 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC DEXCOM, INC. 9500-27 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R