BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4792536 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00446
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 7, 2015
    Report Date
    January 6, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT#: (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:USER'S MISUNDERSTANDING OF ERRATIC RESULTS.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER EXPECTED BLOOD RESULTS ARE 100-120MG/DL VERIFIED THE STRIPS EXPIRE 04/30/2017. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 325MG/DL AND 273 MG/DL FASTING. REVIEWED METER MEMORY: 391MG/DL; (B)(6) 2015; 12:25:00 PM FASTING: NO, 126MG/DL; (B)(6) 2015; 11:47:00 PM FASTING: NO, 131MG/DL; (B)(6) 2015; 11:53:24 PM FASTING:, 273MG/DL; (B)(6) 2015; 11:57:00 PM FASTING: NO, 325MG/DL; (B)(6) 2015; 01:54:00 PM FASTING: NO. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 100-120MG/DL. VERIFIED THE STRIPS EXPIRE 04/30/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 325MG/DL AND 273MG/DL FASTING. REVIEWED METER MEMORY: (B)(6). NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280871 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1954

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR