BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4942246 · Received July 23, 2015

    Report

    Report Number
    1052693-2015-01250
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 29, 2015
    Report Date
    December 10, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER'S TEST STRIP HAD POOR STORAGE INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 126-145MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/15/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN AND WERE OPENED ONE WEEK AGO. REVIEWED METER MEMORY: (B)(6). NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 126-145MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/15/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED IN THE KITCHEN AND WERE OPENED ONE WEEK AGO. REVIEWED METER MEMORY: 172MG/DL, (B)(6) 2015, 09:30:00 AM, FASTING: YES; 117MG/DL, (B)(6) 2015, 09:30:00 AM, FASTING: YES; 128MG/DL, (B)(6) 2015, 06:30:00 AM, FASTING: YES; 126MG/DL, (B)(6) 2015, 09:30:00 AM, FASTING: YES; 251MG/DL, (B)(6) 2015, 09:45:00 AM, FASTING: YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479422 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4538

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR