BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4200162 · Received October 21, 2014

    Report

    Report Number
    1052693-2014-00436
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 19, 2014
    Report Date
    December 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4). MANUFACTURER 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) 2014).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". LAST 4 TESTS IN MEMORY: "LO", 120MG/DL, 114MG/DL, 104MG/DL. PERFORMED BACK TO BACK BLOOD TESTS, RESULTS WERE 96 AND 108MG/DL. CUSTOMER'S NORMAL GLUCOSE RANGE IS 110-120MG/DL FASTING AND 120-130MG/DL 2 HOURS AFTER EATING. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO." LAST 4 TESTS IN MEMORY: "LO", 120 MG/DL, 114 MG/DL, AND 104 MG/DL. PERFORMED BACK TO BACK BLOOD TESTS, RESULTS WERE 96 AND 108 MG/DL. CUSTOMER'S NORMAL GLUCOSE RANGE IS 110-120 MG/DL FASTING AND 120-130 MG/DL 2 HOURS AFTER EATING. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670368 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1502

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR