BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5131588 · Received October 7, 2015

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    Report

    Report Number
    1052693-2015-01920
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    September 16, 2015
    Report Date
    June 27, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: STRIP ISSUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HI RESULTS. CUSTOMER STATES SHE FEELS WELL AND DOES NOT REQUIRE ANY MEDICAL ATTENTION AT THIS TIME. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 146-227MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/31/2018. CUSTOMER COULD NOT CONFIRM WHEN THE TEST STRIPS WERE FIRST OPENED BUT STATES THE STRIPS WERE PROPERLY STORED. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST HI AND HI NOT FASTING. REVIEWED METER MEMORY: (B)(6). CUSTOMERS CONCERN:ABOUT ALL THE RESULTS. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF HI RESULTS. CUSTOMER STATES SHE FEELS WELL AND DOES NOT REQUIRE ANY MEDICAL ATTENTION AT THIS TIME. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 146-227MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 05/31/2018. CUSTOMER COULD NOT CONFIRM WHEN THE TEST STRIPS WERE FIRST OPENED BUT STATES THE STRIPS WERE PROPERLY STORED. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST HI AND HI NOT FASTING. REVIEWED METER MEMORY: HI (B)(6) 2015 04:12:00 AM FASTING:YES; THE 368MG/DL (B)(6) 2015 01:46:00 AM FASTING:YES; THE 582MG/DL (B)(6) 2015 09:48:00 AM FASTING:YES; THE HI (B)(6) 2015 09:46:00 AM FASTING:YES; THE 257MG/DL (B)(6) 2015 03:03:00 AM FASTING:YES. CUSTOMERS CONCERN:ABOUT ALL THE RESULTS. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662526 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2365

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR