BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4808545 · Received May 28, 2015

    Report

    Report Number
    1052693-2015-00803
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 29, 2015
    Report Date
    December 17, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAD AN INACCURATE REFERENCE. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. PRODUCT CODES UPDATED (68 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 120-135MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. CUSTOMER WAS UNABLE TO CONFIRM WHEN THE TEST STRIPS WERE FIRST OPENED. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 186MG/DL AND 177MG/DL FASTING. 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 120-135MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. CUSTOMER WAS UNABLE TO CONFIRM WHEN THE TEST STRIPS WERE FIRST OPENED. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 186MG/DL AND 177MG/DL FASTING. REVIEWED METER MEMORY: 1:206MG/DL (B)(6) 2015 09:42:59 AM FASTING: YES; 2:405MG/DL (B)(6) 2015 09:42:59 AM FASTING: YES; 3:163MG/DL (B)(6) 2015 09:42:59 AM FASTING: YES; 4:182MG/DL (B)(6) 2015 09:42:59 AM FASTING: YES; 5:179MG/DL (B)(6) 2015 09:42:59 AM FASTING: YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344769 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1988

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR