BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6348727 · Received February 22, 2017

    Report

    Report Number
    1000113657-2017-00358
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    January 31, 2017
    Report Date
    February 22, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007584
    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 OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 200, 184 AND 168 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 150 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 244 MG/DL USING TRUEMETRIX AIR METER AND 232 MG/DL USING TRUEMETRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2018 AND OPEN VIAL DATE IS (B)(6) 2016. CUSTOMER STATED THE RESULT OF 373 MG/DL IN THE METER MEMORY WAS OBTAINED BY USING A CONTROL SOLUTION BELONGING TO A DIFFERENT BRAND OF METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: THE CUSTOMER IS CONCERNED WITH ALL OF THE READINGS IN THE MEMORY EXCEPT THE 373. THE 373 READING WAS OBTAINED BY USING A CONTROL SOLUTION FOR ANOTHER METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133438 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1922 00021292007584

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY