BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4924454 · Received July 16, 2015

    Report

    Report Number
    1052693-2015-01184
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 22, 2015
    Report Date
    December 11, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 121-161MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 01/22/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 129MG/DL AND 131MG/DL FASTING. REVIEWED METER MEMORY: SEE SCANNED TABLE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 121-161MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 01/22/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED ON (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 129MG/DL AND 131MG/DL FASTING. REVIEWED METER MEMORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463751 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2204

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR