BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 4841434 · Received June 12, 2015

    Report

    Report Number
    1056600-2015-00056
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    April 16, 2015
    Report Date
    June 12, 2015
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND PROVIDED SECOND LEVEL ENGINEERING WITH BEFORE AND AFTER IMAGES OF THE REFERENCE CARD. ALSO RECORDED BRILLO READING OF 111. THE FE DID OPTICS ALIGNMENT AND ADJUSTMENTS, INCLUDING FINE ADJUSTMENT. THE FE GENERATED A NEW REFERENCE IMAGE. THE FE RAN CONTROLS TO VERIFY QC AND CORRECT INSTRUMENT OPERATION. CONTROLS AND QC VERIFIED AND ACCEPTED BY THE CUSTOMER. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    LOG FILES WERE PROVIDED TO (B)(4) FOR REVIEW. DURING REVIEW, IT WAS IDENTIFIED THAT THE READER CAMERA BRIGHTNESS WAS OUT OF SPECIFICATION (CAMERA BRIGHTNESS SETTING AT 131 AND SHOULD BE BETWEEN 101 - 128). CAMERA OUT OF SPEC FROM (B)(6). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385946 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1