BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6096360 · Received November 11, 2016

    Report

    Report Number
    3004753838-2016-23088
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 22, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2016. REPORTEDLY, THE PATIENT USED MULTIPLE BG METERS THROUGHOUT THE SAME SENSOR SESSION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED INACCURACY COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. LABELING INDICATES: FINGER STICK BG VALUE WILL VARY FROM METER TO METER, AND TEST TO TEST. IT IS IMPORTANT THAT THE PATIENT USE THE SAME COMMERCIALLY DISTRIBUTED BG METER DURING THEIR SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747684 T:SLIM G4 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC DEXCOM, INC. 9500-27 5215766 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR