BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2032240 · Received March 29, 2011

    Report

    Report Number
    1056600-2011-00023
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 29, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND PERFORMED THE READER CAMERA ALIGNMENT AND OPTICS ADJUSTMENTS. THE CUSTOMER RAN CONTROLS WHICH PERFORMED TO SPECIFICATION. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ORTHO PROVUE MISSED AN ANTIBODY THAT WAS DETECTED IN MANUAL GEL. NO ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THIS INCIDENT. THERE WAS NO HARM TO ANY PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1