BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4702005 · Received April 15, 2015

    Report

    Report Number
    1052693-2015-00630
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    August 28, 2013
    Report Date
    April 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED FOR EVALUATION. (B)(4). MFR ACKNOWLEDGES LATENESS OF THE REPORT, PER INTERNAL CORRECTIVE ACTION. THIS REPORT SHOULD HAVE BEEN IDENTIFIED AS REPORTABLE WITHIN 30 DAYS OF THE IDENTIFICATION ((B)(6) 2013). MOST LIKELY UNDERLYING ROOT CAUSE: USE HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. VERIFIED THE STRIPS EXPIRE 04/29/2015. CUSTOMER STATED THAT HIS EXPECTED RESULT AVERAGES 102-130 MG/DL. RESULTS FROM THE METER MEMORY: CUSTOMER DECLINED TO RUN A BACK TO BACK TEST BECAUSE IT WILL NOT BE A FASTING TEST. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252645 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1307

    Patients

    Seq Age Sex Outcome Treatment
    1