BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 5033299 · Received August 26, 2015

    Report

    Report Number
    1052693-2015-01496
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 28, 2015
    Report Date
    October 21, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET EVALUATED.

    Description of Event or Problem · 1

    CUSTOMER IS COMPLAINING THAT HIS METER IS READING HIGH. CUSTOMER IS FEELING WELL WITH NO MEDICAL ATTENTION NEEDED AT THIS TIME. EXPECTED RESULTS:108-123MG/DL FASTING. TEST STRIP EXPIRATION DATE 08/25/2017. DATE TEST STRIP VIAL WAS OPENED (B)(6) 2015. TEST STRIPS STORED CORRECTLY. BACK TO BACK BLOOD GLUCOSE TESTS RESULTED IN: BLOOD TEST 1:158MG/DL FASTING. BLOOD TEST 2:140MG/DL FASTING. REVIEWED METER MEMORY: 1:151MG/DL (B)(6) 2015 08:11:00 AM FASTING:YES. 2:146MG/DL (B)(6) 2015 08:15:00 AM FASTING:YES. 3:113MG/DL (B)(6) 2015 06:42:00 AM FASTING:YES. 4:211MG/DL (B)(6) 2015 06:40:00 AM FASTING:YES. 5:138MG/DL (B)(6) 2015 08:21:00 AM FASTING:YES. CUSTOMERS CONCERN:WITH 211MG/DL(B)(6) 2015 2 6:40AM. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HIGH RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 108-123MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 08/25/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 158MG/DL AND 140MG/DL FASTING. REVIEWED METER MEMORY: 151MG/DL (B)(6) 2015 08:11:00 AM FASTING:YES; 146MG/DL (B)(6) 2015 08:15:00 AM FASTING:YES; 113MG/DL (B)(6) 2015 06:42:00 AM FASTING:YES; 211MG/DL (B)(6) 2015 06:40:00 AM FASTING:YES; 138MG/DL (B)(6) 2015 08:21:00 AM FASTING:YES. CUSTOMERS CONCERN WITH 211MG/DL (B)(6) 2015 2 6:40AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564577 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4620

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR