BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 7049077 · Received November 21, 2017

    Report

    Report Number
    1000113657-2017-01984
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 21, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00311917173894
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS.THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED RESULTS OF 186MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-114 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 158 AND 186MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/23/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 130MG/DL DATE: (B)(6) 2017TIME: 03:55FASTING, RESULT 2: 134MG/DL DATE: (B)(6) 2017TIME: 03:50FASTING, RESULT 3: 149 MG/DL DATE: (B)(6) 2017TIME 03:36 FASTING, RESULT 4: 116 MG/DL DATE: (B)(6) 2017TIME: 07:41 FASTING, RESULT 5: 115MG/DL DATE: (B)(6) 2017 TIME: 17:40 FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829832 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1995 00311917173894

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR