BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4894415 · Received July 1, 2015

    Report

    Report Number
    1052693-2015-01026
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 5, 2015
    Report Date
    December 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: THE USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 75-100MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/31/2016. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 97MG/DL AND 98MG/DL FASTING. REVIEW METER MEMORY: 277MG/DL, (B)(6) 2015, 07:44:00 AM, FASTING: YES; 201MG/DL, (B)(6) 2015, 07:11:00 AM, FASTING: YES; 186MG/DL, (B)(6) 2015, 07:00:00 AM, FASTING: YES; 4:165MG/DL, (B)(6) 2015, 07:18:00 AM, FASTING: YES; 5:138MG/DL, (B)(6) 2015, 07:00:00 AM, FASTING: YES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 75-100MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/31/2016. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 97MG/DL AND 98MG/DL FASTING. REVIEWED METER MEMORY: 1:277MG/DL (B)(6) 2015 07:44:00 AM FASTING:YES. 2:201MG/DL (B)(6) 2015 07:11:00 AM FASTING:YES. 3:186MG/DL (B)(6) 2015 07:00:00 AM FASTING:YES. 4:165MG/DL (B)(6) 2015 07:18:00 AM FASTING:YES. 5:138MG/DL (B)(6) 2015 07:00:00 AM FASTING:YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429675 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4324

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR