BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6028368 · Received October 13, 2016

    Report

    Report Number
    3004753838-2016-67198
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A SENSOR (SERIAL NUMBER (B)(4)/LOT NUMBER 5211764) WAS RETURNED FOR EVALUATION. AN INVESTIGATION WAS UNABLE TO BE PERFORMED BECAUSE THE RETURNED PRODUCT WOULD NOT BE ABLE TO CONFIRM THE REPORTED EVENT OF INACCURACIES. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THERE WERE INACCURACIES 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 ENTERED FINGER STICK VALUES DURING LOSS OF SIGNAL. ADDITIONALLY, 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: DO NOT CALIBRATE IF THE OUT OF RANGE SYMBOL SHOWS IN THE STATUS AREA. LABELING INDICATES: MAKE SURE YOU HAVE NOT TAKEN ANY MEDICATIONS CONTAINING ACETAMINOPHEN (SUCH AS TYLENOL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678245 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5211879 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR