BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5445252 · Received February 18, 2016

    Report

    Report Number
    1052693-2016-00306
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Date of Event
    January 26, 2016
    Report Date
    February 18, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURNED FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD A POOR STORAGE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULT IS 120-160MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 10/21/2018. CUSTOMER CONFIRMS THE STRIPS HAVE BEEN STORED IN THE KITCHEN AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED A BACK TO BACK BLOOD TEST AND OBTAINED 65MG/DL AND 69MG/DL FASTING. REVIEWED METER MEMORY 78MG/DL, (B)(6) 2016 04:33:00 PM, FASTING:YES. 65MG/DL, (B)(6) 2016 02:59:00 PM, FASTING:YES. 58MG/DL, (B)(6) 2016 11:00:00 AM, FASTING:YES. 150MG/DL, (B)(6) 2016 04:04:00 PM, FASTING:YES. 138MG/DL, (B)(6) 2016 12:44:00 PM, FASTING:YES. MEMORY CONCERNS:78,65,58MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100370 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2542

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR