BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4373217 · Received December 24, 2014

    Report

    Report Number
    1052693-2014-00620
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    November 15, 2014
    Report Date
    December 23, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 (115/2014).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING "HI". THE CUSTOMER STATES THAT HIS EXPECTED BLOOD RESULTS ARE USUALLY IN THE 60MG/DL'S. REVIEWED THE LAST 4 BLOOD RESULTS IN THE METER MEMORY: HI 1:58PM (B)(6); HI 1:56PM (B)(6); 297 1:57PM (B)(6); 112MG/DL 11:44PM (B)(6). THE CUSTOMER FEELS LIKE HIS BLOOD SUGAR MAY BE OVER 600MG/DL DUE TO HIS BIRTHDAY LAST NIGHT AND EATING WAY TOO MUCH. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851097 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2041

    Patients

    Seq Age Sex Outcome Treatment
    1