BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6988828 · Received October 30, 2017

    Report

    Report Number
    1000113657-2017-01880
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 30, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007447
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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'S TEST STRIP HAD POOR STORAGE (BATHROOM) TEST STRIP, (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 131, 215, 233, 162 AND 181 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/27/2017 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 : 131 MG/DL DATE: (B)(6) 2017 TIME: 7:45AM FASTING; RESULT 2 : 215 MG/DL DATE: (B)(6) 2017TIME: 9:14PM FASTING; RESULT 3 : 233 MG/DL DATE: (B)(6) 2017TIME: 9:14PM FASTING; RESULT 4 : 162 MG/DL DATE: (B)(6) 2017 TIME: 7:14AM FASTING; RESULT 5 : 181 MG/DL DATE: (B)(6) 2017 TIME: 7:13 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767803 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1951 00021292007447

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR