BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6121819 · Received November 22, 2016

    Report

    Report Number
    3004753838-2016-29898
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 3, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 AT THE ABDOMEN ON (B)(6) 2016. REPORTEDLY, THE PATIENT TOOK MEDICATION CONTAINING ACETAMINOPHEN AND USED MORE THAN ONE BG METER DURING THEIR 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: MAKE SURE YOU HAVE NOT TAKEN ANY MEDICATIONS CONTAINING ACETAMINOPHEN (SUCH AS TYLENOL). LABELING INDICATES: USE THE SAME METER YOU ROUTINELY USE TO MEASURE YOUR BLOOD GLUCOSE TO CALIBRATE. DO NOT SWITCH YOUR METER IN THE MIDDLE OF A SENSOR SESSION. BLOOD GLUCOSE METER AND STRIP ACCURACY VARY BETWEEN BLOOD GLUCOSE METER BRANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772499 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR