BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6213769 · Received December 29, 2016

    Report

    Report Number
    1000113657-2016-02118
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 29, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007447
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 60, 50 AND 232 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 119 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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 60 MG/DL AND E-2 USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/28/2017 AND OPEN VIAL DATE WAS UNDISCLOSED. THE CUSTOMER STATED HE IS ON INSULIN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: 50, 232, 153 AND 330.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863915 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1693 00021292007447

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY