BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4110721 · Received September 16, 2014

    Report

    Report Number
    1052693-2014-00330
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 16, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEFECT FOUND WITH RETURNED PRODUCT. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE, USER REUSED TEST STRIP, USER'S TEST STRIP HAD POOR FILL.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMALLY IS AROUND 100-120 MG/DL TWO HOURS AFTER A MEAL. PERFORMED BLOOD TEST, RESULT WAS 74 MG/DL. CUSTOMER STATES ALL RESULTS WERE FASTING. LAST 5 RESULTS TO MEMORY WERE 74 MG/DL, 73 MG/DL, 77 MG/DL, 72 MG/DL, AND 73 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (72) AND THE NORMAL RESULT (120) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571850 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR1858

    Patients

    Seq Age Sex Outcome Treatment
    1