BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4702029 · Received April 15, 2015

    Report

    Report Number
    1052693-2015-00527
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 19, 2015
    Report Date
    March 23, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    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: USER HAD INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. "LO". CUSTOMER'S HUSBAND, (B)(6) IS CALLING ON BEHALF OF HIS WIFE. CUSTOMER'S HUSBAND STATES THAT THE CUSTOMER FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER STATES THAT THE RESULTS OBTAINED DO NOT REFLECT HOW WELL SHE FEELS. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 100-125MG/DL. VERIFIED THE STRIPS EXPIRE 10/21/2017 AND FIRST OPENED THE TEST STRIPS (B)(6) 2015. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY. REVIEWED METER MEMORY: 526MG/DL; 03/19/2015; 06:52:00 AM; FASTING: NO, 173MG/DL; 03/18/2015; 05:14:00 PM; FASTING: YES, 105MG/DL; 03/18/2015; 02:01:00 PM; FASTING: YES, 242MG/DL; 03/18/2015; 10:40:00 AM; FASTING: NO, 393MG/DL; 03/18/2015; 09:23:00 AM; FASTING: YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252660 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2136

    Patients

    Seq Age Sex Outcome Treatment
    1