BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4688756 · Received April 9, 2015

    Report

    Report Number
    1052693-2015-00405
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 14, 2015
    Report Date
    April 10, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: TEST STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULTS READING OF "LO". CUSTOMER FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMERS EXPECTED BLOOD RESULTS ARE 80-110MG/DL. VERIFIED THE STRIPS EXPIRE 08/26/2017, WERE FIRST OPENED YESTERDAY AND THAT THE STRIPS ARE STORED CORRECTLY. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST, 235MG/DL AND 223MG/DL. REVIEWED METER MEMORY: 79MG/DL (B)(6) 2015, 07:52:41 AM, FASTING: YES; 81MG/DL (B)(6) 2015, 04:48:41 AM, FASTING: YES; 48MG/DL, (B)(6) 2015 07:46:41 AM, FASTING YES; LO (B)(6) 2015, 07:44:41 AM, FASTING: YES; 83MG/DL, (B)(6) 2015, 07:20:40 AM, FASTING: YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233547 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2081

    Patients

    Seq Age Sex Outcome Treatment
    1