BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2142434 · Received June 28, 2011

    Report

    Report Number
    1056600-2011-00059
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND REPLACED THE SYRINGE. THE FE ALSO SENT THE PROVUE LOG FILES TO SECOND LEVEL SUPPORT FOR REVIEW. THE REVIEW OF THE PROVUE LOG FILES WERE GOOD. THE CUSTOMER RAN AND ACCEPTED QC. REPAIRS HAVE RETURNED THE 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. NO ERRONEOUS OR INCORRECT RESULTS WERE REPORTED.

    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