BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1842739 · Received September 23, 2010

    Report

    Report Number
    1056600-2010-00118
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER ARRIVED ON SITE AND OBSERVED THE FINE PROBE ALIGNMENT OFF. THE FE READJUSTED THE CAMERA AND PERFORMED DIAGNOSTICS. ALL DIAGNOSTICS CHECKS WERE GOOD. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE MISSED AN ANTIBODY THAT WAS DETECTED IN MANUAL GEL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1