BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1241616 · Received November 19, 2008

    Report

    Report Number
    1056600-2008-00335
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 19, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER VISITED THE SITE, REPLACED APPROPRIATE PARTS AND ADJUSTED THE READER CAMERA. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ORTHO PROVUE ANALYZER INTERPRETED A PATIENT'S SAMPLE CONTAINING ANTI-LEA AS NEGATIVE. VISUAL INSPECTION OF THE PROCESSED GEL CARD SHOWED A VERY WEAK REACTION WITH THE LEA POSITIVE DONOR CELL. THE CUSTOMER REPEATED THE SAMPLE IN MANUAL GEL TEST USING THE SAME LOT OF REAGENTS AND GEL CARDS AND OBTAINED WEAK POSITIVE REACTIVITY. 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 SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1