BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 7067196 · Received November 29, 2017

    Report

    Report Number
    1000113657-2017-02000
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 29, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00311917173894
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4) -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. TEST STRIP UDI# (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120MG/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 DATE, A BACK TO BACK BLOOD TEST WAS PERFORMED NONFASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 280 AND 323MG/DL USING TRUE METRIX AIR METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/15/1208 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 :202 MG/DL DATE: (B)(6) TIME:10:06 AM FASTING. RESULT 2 :266 MG/DL DATE: (B)(6) TIME:10:20 PM FASTING. RESULT 3 :219 MG/DL DATE: (B)(6) TIME:12:18 PM FASTING. RESULT 4 :200 MG/DL DATE: (B)(6) TIME:10:08 PM FASTING. RESULT 5 :241 MG/DL DATE: (B)(6) TIME:10:43 PM FASTING. CUSTOMER STATES THAT WHEN TESTING, HIS RESULTS ARE HIGHER THAN NORMAL FASTING. NO CHANGES TO EXERCISE AND/OR DIET ROUTINE. DATE AND TIME NOT CURRENTLY SET UP IN THE METER CORRECTLY. CUSTOMER IS CONCERNED WITH THE HIGH RESULTS FROM THE METER AND THE CUSTOMER IS ALSO CONCERNED WITH THE VARIANCE IN THE RESULTS FROM THE BACK TO BACK BLOOD TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846383 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MU2515 00311917173894

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR