BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4373227 · Received December 24, 2014

    Report

    Report Number
    1052693-2014-00613
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    November 13, 2014
    Report Date
    January 5, 2016
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 (11/13/2014).

    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. PRODUCT CODES UPDATED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". THE CUSTOMER CONFIRMS WHEN USING THIS SPECIFIC VIAL, LOT NUMBER PR1862: THE METER DISPLAYS "LO". THE LAST 3 RESULTS FROM THE METER MEMORY: 101MG/DL, ON (B)(6) 2014 - 04:39PM. LO, ON (B)(6) 2014 - 04:37PM. LO, ON (B)(6) 2014 - 04:36PM. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO". THE CUSTOMER CONFIRMS WHEN USING THIS SPECIFIC VIAL, LOT NUMBER PR1862: THE METER DISPLAYS "LO". THE LAST 3 RESULTS FORM THE METER MEMORY: 101MG/DL ON (B)(6) 2014 - 04:39PM; LO ON (B)(6) 2014 - 04:37PM; LO ON (B)(6) 2014 - 04:36PM. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851099 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1862

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR