BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 5955975 · Received September 16, 2016

    Report

    Report Number
    1000113657-2016-01553
    Event Type
    Malfunction
    Date Received
    September 16, 2016
    Date of Event
    August 23, 2016
    Report Date
    September 29, 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). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND ON RETURNED METER AND RETURNED TEST STRIPS. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURN FOR EVALUATION YET. 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. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 181, 191, 194, 204 AND 181 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160 MG/DL. AT TIME OF CALL ON (B)(6) 2016, THE CUSTOMER REPORTED FEELING WELL AND DID NOT REPORT ANY SYMPTOMS. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/13/2017 AND HAVE BEEN OPENED FOR TWO MONTHS AT TIME OF CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: CUSTOMER IS CONCERN WITH ALL THESE RESULTS. CUSTOMER STATES THAT THE READING ARE NOT IN LINE WITH THE A1C TEST THAT THE TRUEMETRIX METER IS GIVING. CUSTOMER NEVER HAD A RESULTS ABOVE 200MG/DL BEFORE. CUSTOMER STATES THAT BECAUSE OF THE HIGH RESULTS;CUSTOMER WENT TO THE DOCTOR OFFICE TO GET A A1C TEST DONE AND THE A1C WAS 6.5 AND THE RESULTS WAS WITHIN RANGE. CUSTOMER TEST TWICE A DAY.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 181, 191, 194, 204 AND 181 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160 MG/DL. AT TIME OF CALL ON (B)(6) 2016, THE CUSTOMER REPORTED FEELING WELL AND DID NOT REPORT ANY SYMPTOMS. DURING THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/13/2017 AND HAVE BEEN OPENED FOR TWO MONTHS AT TIME OF CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: CUSTOMER IS CONCERN WITH ALL THESE RESULTS. CUSTOMER STATES THAT THE READING ARE NOT IN LINE WITH THE A1C TEST THAT THE TRUEMETRIX METER IS GIVING. CUSTOMER NEVER HAD A RESULTS ABOVE 200MG/DL BEFORE. CUSTOMER STATES THAT BECAUSE OF THE HIGH RESULTS; CUSTOMER WENT TO THE DOCTOR OFFICE TO GET A A1C TEST DONE AND THE A1C WAS 6.5 AND THE RESULTS WAS WITHIN RANGE. CUSTOMER TEST TWICE A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608401 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1665

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY