BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4110734 · Received September 16, 2014

    Report

    Report Number
    1052693-2014-00318
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 8, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFECT FOUND WITH RETURNED PRODUCT. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: INTERFERENTS PRESENT IN USER BLOOD, USER REFERENCED DIFFERENT DEVICE DURING CALL, USER HAD AN INACCURATE REFERENCE. INTERNAL REPORT NUMBER (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)(4) 2014).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "LO." ANOTHER TEST PERFORMED ALSO READ "LO." LAST 5 TESTS IN MEMORY: "LO", "LO", "HI", 103 MG/DL, "HI", "HI", "LO." NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572309 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS INC. TRUERESULT PP1308

    Patients

    Seq Age Sex Outcome Treatment
    1