BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4874078 · Received June 25, 2015

    Report

    Report Number
    1052693-2015-00982
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 31, 2015
    Report Date
    December 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION STRIP ISSUE. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. ( CODE NO LONGER AVAILABLE).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT ABOUT BLOOD RESULT READING "LO". CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 120-140MG/DL,FASTING. VERIFIED THE STRIPS EXPIRE 08/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 139MG/DL AND 212MG/DL,FASTING. REVIEWED METER MEMORY: 71MG/DL, (B)(6) 2015 03:10:00 PM, FASTING:YES. 147MG/DL, (B)(6) 2015 03:08:00 PM, FASTING: YES. LO, (B)(6) 2015 03:06:00 PM, FASTING: YES. 170MG/DL, (B)(6) 2015 03:05:00 PM, FASTING: YES. 359MG/DL, (B)(6) 2015 03:04:00 PM, FASTING: YES. CUSTOMERS METER IS NOT AFFECTED BY THE VOLUNTARY RECALL.,

    Description of Event or Problem · 1

    CONSUMER COMPLAINT ABOUT BLOOD RESULT READING "LO". CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 120-140MG/DL,FASTING. VERIFIED THE STRIPS EXPIRE 08/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 139MG/DL AND 212MG/DL,FASTING. REVIEWED METER MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411695 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RS4630

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR