BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6029650 · Received October 14, 2016

    Report

    Report Number
    1000113657-2016-01709
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 18, 2016
    Report Date
    October 14, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. 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 IS CONCERNED WITH TEST RESULTS FROM FASTING RESULTS OBTAINED OF 233, 221 AND 217 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 99 - 110 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 NON-FASTING AND PRODUCED TEST RESULTS OF 130 MG/DL AND 133 MG/DL . THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE MANUFACTURER'S EXPIRATION DATE IS 12/14/2017 AND OPEN VIAL DATE IS 09/15/2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 233MG/DL, (B)(6) 2016, 07:15 AM, FASTING: YES; 221MG/DL, (B)(6) 2016, 07:50 AM, FASTING: YES; 217MG/DL, (B)(6) 2016, 07:48 AM, FASTING: YES; 162MG/DL, (B)(6) 2016, 07:28 AM, FASTING: YES; 154MG/DL, (B)(6) 2016, 07:20 AM, FASTING: YES. MEMORY CONCERNS: 233 221 217 162 154MG/DL. CUSTOMER DOES NOT HAVE CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680646 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1844

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY