BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6105870 · Received November 16, 2016

    Report

    Report Number
    3004753838-2016-52763
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 21, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND SEIZURES.

    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, THE PATIENT EXPERIENCED CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO THE BLOOD GLUCOSE (BG) METER AND AN ADVERSE EVENT. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2016. PATIENT'S MOTHER STATED THAT THE PATIENT HAD A SEIZURE DURING THE NIGHT AND PATIENT'S MOTHER HAD TO ADMINISTER A GLUCAGON SHOT. PATIENT'S MOTHER INDICATED THAT THE SEIZURE WAS CAUSED BY THE CGM INACCURACY AND REPORTED THAT THE CGM WAS READING 85MG/DL COMPARED TO THE BG METER WHICH READ 31MG/DL. AT THE TIME OF CONTACT, THE PATIENT WAS FINE. ADDITIONAL EVENT OR PATIENT INFORMATION IS NOT AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF CGM INACCURACY WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A TRANSMITTER (PART NUMBER STT-GF-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5211703) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURES WERE DETECTED. A PAIRING TEST WAS PERFORMED AND THE TES PASSED. A REVIEW OF THE SHARED DATA LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE REPORTED EVENT OF INACCURACIES WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. IT IS UNKNOWN IF THE RETURNED DEVICE IS THE PRODUCT AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757816 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 NI 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other