BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 5810442 · Received July 20, 2016

    Report

    Report Number
    1052693-2016-01236
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 20, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER'S EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 105MG/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 175 AND 211 MG/DL. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/28/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: TRUE METRIX AIR 175 ON (B)(6) 2016 07:00:00 AM FASTING. TRUE METRIXAIR 211 ON (B)(6) 2016 07:00:00 AM FASTING. TRUE METRIXAIR 185 ON (B)(6) 2016 07:00:00 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464051 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1499

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR