BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 5232595 · Received November 18, 2015

    Report

    Report Number
    1056600-2015-00099
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    August 18, 2014
    Report Date
    November 18, 2015
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD REP CONTACTED CTS TO REPORT THE FINDINGS ON 10-21-2015 OF THE READER CAMERA BRIGHTNESS SETTING TO BE OUT OF SPECIFICATION (101-128) WHILE ON SITE TO PERFORM MOD 41 (TO CHECK IF THE READER CAMERA ADJUSTMENT VALUE IS WITHIN THE LISTED RANGE). FE HAS IDENTIFIED CURRENT CAMERA BRIGHT CAMERA SETTING TO BE 131 IN THE INSTRUMENT LOG FILE. WHILE LOOKING BACK THROUGH THE LOG FILES, IT WAS NOTICED THAT ON (B)(6) 2014, THE CAMERA WAS SET AT 129. AT SOME POINT BETWEEN (B)(6) 2014 AND (B)(6) 2015, THE CAMERA SETUP WAS CHANGED FROM 129 TO 131 (STILL OUT SIDE OF 101-128 RANGE). THE CUSTOMER IS UNABLE TO CONFIRM NO ERRONEOUS RESULTS HAVE BEEN REPORTED DUE TO THE LENGTH OF TIME THE OUT OF SPECIFICATION CONDITION HAS EXISTED. THE FE INFORMED THE CUSTOMER OF THE OUT OF SPEC FINDING. ALSO, FE INFORMED THE CUSTOMER THAT FINDINGS AND CONCERNS ARE UNDER INVESTIGATION AND FOLLOW UP WILL BE MADE BY ORTHO.

    Description of Event or Problem · 1

    THE FE DISCOVERED THAT THE PROVUE CAMERA SETTING WAS OUT OF SPECIFICATION. THE LOGS SHOWED THE SETTING HAS BEEN OUT OF RANGE SINCE (B)(6) 2014. THE CUSTOMER IS UNABLE TO CONFIRM NO ERRONEOUS RESULTS HAVE BEEN REPORTED DUE TO THE LENGTH OF TIME THE OUT OF SPECIFICATION CONDITION HAS EXISTED. THE FE ADJUSTED THE SETTING AND INFORMED THE CUSTOMER OF THE OUT OF SPECIFICATION FINDING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762748 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1

    Patients

    Seq Age Sex Outcome Treatment
    1