BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5039534 · Received August 28, 2015

    Report

    Report Number
    1052693-2015-01542
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 28, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IN PROCESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 95-110MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 09/30/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: 1: 84MG/DL (B)(6) 2015 6:30AM; 2: 74MG/DL (B)(6) 2015 7:20AM; 3: 69MG/DL (B)(6) 2015 9:30AM; 4: 73MG/DL (B)(6) 2015 6:30AM; 5: 79MG/DL (B)(6) 2015 6:30AM. CUSTOMERS CONCERN: 79MG/DL (B)(6) 2015 6:30AM ,73MG/DL; (B)(6) 2015 6:30AM ,69 MG/DL; (B)(6) 2015 9:30AM AND 74 MG/DL (B)(6) 2015 7:20AM. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571007 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2120

    Patients

    Seq Age Sex Outcome Treatment
    1