BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3979028 · Received July 3, 2014

    Report

    Report Number
    1052693-2014-00186
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    February 22, 2011
    Report Date
    July 3, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED. DUE TO FDA INSPECTION RECOMMENDATION, A REPORT WAS FILED. REFERENCE 1052693-2013-007. MW5019473. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION WAS SOFTWARE ERROR. CAPA (B)(4) INITIATED AND CORRECTIVE ACTION WAS VERIFIED.

    Description of Event or Problem · 1

    DR. (B)(6) STATED THAT (B)(6) APPARENTLY HAS SEEN SEVERAL METERS THAT NORMAL RESULTS ARE BEING ENTERED INTO MEMORY AS A "HI" VALUE. SHE IS OUT OF THE OFFICE UNTIL (B)(6) AND A DETAILED VOICE MAIL ASKING THAT SHE CALL TO DISCUSS THIS MATTER AND MAKE ARRANGEMENTS TO HAVE THEM RETURNED. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392307 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1