BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 5250918 · Received November 25, 2015

    Report

    Report Number
    1056600-2015-00103
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    August 16, 2011
    Report Date
    November 25, 2015
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FE PERFORMED THE CAMERA ADJUSTMENTS IN ACCORDANCE WITH THE CURRENT SERVICE CD GUIDELINES. A NEW REFERENCE IMAGE HAS BEEN TAKEN AND THE CAMERA NOW READS 110 (SPEC 101-128) WHICH IS WITHIN THE SPECIFICATIONS REQUIRED. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE FE DISCOVERED THAT THE PROVUE CAMERA SETTING WAS OUT OF SPECIFICATION. THE LOG SHOWED THE SETTING TO BE AT 130 WHICH IS OUT OF SPECIFICATION. THE READER CAMERA WAS OUT OF SPECIFICATION ON 3 DIFFERENT OCCASIONS. 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 SPECIFICATION FINDING. THIS IS 2 OF 3 INCIDENTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781347 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1