BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3913261 · Received July 3, 2014

    Report

    Report Number
    1056600-2014-00036
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON 6-13-2014 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND FOUND TOP PISTON ON THE SYRINGE SLIGHTLY DELAMINATED. CHANGED SYRINGE. THE FE ALSO MEASURED THE READER CAMERA AND FOUND SETTINGS AT 108. THE FE ADJUSTED THE CAMERA TO 119. THE FE RAN A NEW REFERENCE IMAGE. THE CUSTOMER RAN AND APPROVED QC AND SAMPLES. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE PROVUE GAVE FALSE NEGATIVE RESULTS DURING AN ANTIBODY SCREEN TEST FOR A SAMPLE THAT WAS VISUALLY CONFIRMED WEAK POSITIVE. NO ERRONEOUS RESULTS WERE REPORTED (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390113 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1