BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1231005 · Received October 28, 2008

    Report

    Report Number
    1056600-2008-00323
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 28, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER ARRIVED AT THE SITE AND FOUND THAT THE PROBE WAS BENT. THE FE ALSO FOUND A LEAK AT THE CLOT DETECTION BOARD WHICH WAS ORIGINATING FROM THE SYRINGE PUMP. REPLACEMENT OF THE APPROPRIATE COMPONENTS AND ADJUSTMENTS HAS RETURNED THE INSTRUMENT TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FINDING DROPLETS ON TOP OF THE GEL CARD FOIL DURING QC TESTING ON THE ORTHO PROVUE ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED. FLUID ON TOP OF THE GEL CARD FOIL COULD LEAD TO CARRY OVER AND/OR CROSS CONTAMINATION, WHICH COULD LEAD TO ERRONEOUS TEST RESULTS AND 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