BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4792500 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00657
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 3, 2015
    Report Date
    April 27, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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'S TEST STRIPS HAD POOR STORAGE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT BLOOD RESULT READING LOW. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 80-160MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 06/29/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED THE WEEK OF (B)(6) 2015. REVIEWED METER MEMORY: 27MG/DL (B)(6) 2015 09:30:00 AM FASTING: NO, 93MG/DL (B)(6) 2015 06:52:00 AM FASTING: YES, 40MG/DL (B)(6) 2015 07:53:00 PM FASTING: YES, 132MG/DL (B)(6) 2015 06:00:00 PM FASTING: YES, 136MG/DL (B)(6) 2015 04:24:00 PM FASTING: YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281098 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4583

    Patients

    Seq Age Sex Outcome Treatment
    1