BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4874104 · Received June 25, 2015

    Report

    Report Number
    1052693-2015-00975
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 30, 2015
    Report Date
    December 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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. PRODUCT CODES: (CODE NO LONGER AVAILABLE).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 120-125MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/30/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED ON THE KITCHEN TABLE AND THAT THE STRIPS WERE FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: 227MG/DL, (B)(6) 2015 09:15:00 AM, FASTING: YES. 236MG/DL, (B)(6) 2015 08:30:00 AM, FASTING: YES. 176MG/DL, (B)(6) 2015 08:00:00 AM, FASTING: YES. 181MG/DL, (B)(6) 2015 09:30:00 AM, FASTING: YES. 172MG/DL, (B)(6) 2015 09:30:00 AM, FASTING: YES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 120-125MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 11/30/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED ON THE KITCHEN TABLE AND THAT THE STRIPS WERE FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: 1:227MG/DL, (B)(6) 2015, 09:15:00 AM, FASTING: YES; 2:236MG/DL, (B)(6) 2015, 08:30:00 AM, FASTING: YES; 3:176MG/DL, (B)(6) 2015, 08:00:00 AM, FASTING: YES; 4:181MG/DL, (B)(6) 2015, 09:30:00 AM, FASTING: YES; 5:172MG/DL, (B)(6) 2015, 09:30:00 AM, FASTING: YES; NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412298 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2175

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR