BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6206010 · Received December 27, 2016

    Report

    Report Number
    3004753838-2016-94264
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 INSERTION SITE AND DATE ARE UNKNOWN. REPORTEDLY, THE PATIENT WAS TAKING MEDICATION CONTAINING ACETAMINOPHEN. 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: TAKING MEDICATIONS WITH ACETAMINOPHEN (SUCH AS TYLENOL OR EXCEDRIN EXTRA STRENGTH) WHILE WEARING THE SENSOR MAY FALSELY RAISE YOUR SENSOR GLUCOSE READINGS. THE LEVEL OF INACCURACY DEPENDS ON THE AMOUNT OF ACETAMINOPHEN ACTIVE IN YOUR BODY AND IS DIFFERENT FOR EACH PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856752 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR