BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5014618 · Received August 13, 2015

    Report

    Report Number
    1052693-2015-01390
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 15, 2015
    Report Date
    December 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION STRIP ISSUE OR USER HAS HIGH GLUCOSE VALUE. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED PRODUCT PENDING EVALUATION RESULTS.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". CUSTOMER STATES THAT HE TESTED WITH HIS TRUERESULT METER ON HIS GRANDSON AND OBTAINED A "HI"-FASTING THREE TIMES. HIS GRANDSON IS NOT A DIABETIC. CUSTOMER STATES HIS GRANDSON FEELS WELL, BUT THEY SET UP AN APPOINTMENT TO SEE PHYSICIAN DUE TO THESE RESULTS. VERIFIED THE STRIPS EXPIRE 06/23/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: 1:HI (B)(6) 2015 11:40:00 AM FASTING:YES. 2:HI (B)(6) 2015 04:00:00 PM FASTING:YES. 3:HI (B)(6) 2015 04:00:00 PM FASTING:YES. CUSTOMER DISCLOSED THAT BLOOD TEST WERE PERFORMED USING AN ALTERNATE SITE, THE FOREARM.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". CUSTOMER STATES THAT HE TESTED WITH HIS TRUE RESULT METER ON HIS GRANDSON AND OBTAINED A "HI"-FASTING THREE TIMES. HIS GRANDSON IS NOT A DIABETIC. CUSTOMER STATES HIS GRANDSON FEELS WELL, BUT THEY SET UP AN APPOINTMENT TO SEE PHYSICIAN DUE TO THESE RESULTS. VERIFIED THE STRIPS EXPIRE 06/23/2017. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WAS FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: HI, (B)(6) 2015 11:40:00 AM FASTING: YES; HI, (B)(6) 2015 04:00:00 PM FASTING: YES; HI, (B)(6) 2015 04:00:00 PM FASTING: YES. CUSTOMER DISCLOSED THAT BLOOD TEST WERE PERFORMED USING AN ALTERNATE SITE, THE FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532532 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2016

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR