BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1060819 · Received June 12, 2008

    Report

    Report Number
    1056600-2008-00206
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE WAS DETERMINED. OCD SECOND LEVEL SUPPORT INDICATED THAT THE FIRST SAMPLE WAS ANTI-M (COLD AGGLUTININ) WHICH WILL NOT REACT CONSISTENTLY ON TH ANALYZER SINCE PIPETTING IS PERFORMED AT 37 OC. OCD SECOND LEVEL SUPPORT REVIEWED THE LOG FILES AND INDICATED THAT THE REACTIONS IN THE MICROTUBE LOOKED NEGATIVE AS INTERPRETED BY THE PROVUE. THE FIELD ENGINEER INDICATED THAT REPAIRS WERE NOT REQUIRED SINCE THE ANALYZER WAS PERFORMING AS EXPECTED. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO INSTANCES IN WHICH THE ORTHO PROVUE ANALYZER RESULTED WEAKLY POSITIVE ANTIBODY SCREEN SAMPLES AS NEGATIVE. ONE OF THE SAMPLES CONTAINED ANTI-M. BOTH SAMPLES REACTED WEAKLY POSITIVE IN MANUAL GEL TEST. NO ERRONEOUS RESULTS WERE REPORTED. FALSE NEGATIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1