BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4688819 · Received April 9, 2015

    Report

    Report Number
    1052693-2015-00379
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 9, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPES EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER STATES THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 220-263 MG/DL. VERIFIED THE STRIPS EXPIRED 07/31/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 345 MG/DL AND 370 MG/DL NOT FASTING. REVIEWED METER MEMORY: 465 MG/DL, (B)(6) 2015, 02:40:00 PM, FASTING; 398 MG/DL, (B)(6) 2015, 02:40:00 PM, FASTING; 427 MG/DL, (B)(6) 2015, 02:39:00 PM, FASTING; 428 MG/DL, (B)(6) 2015, 04:01:00 PM, FASTING; 445 MG/DL (B)(6) 2015, 04:00:00 PM, FASTING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233411 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS INC TRUERESULT PR2063

    Patients

    Seq Age Sex Outcome Treatment
    1