BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1060811 · Received June 12, 2008

    Report

    Report Number
    1056600-2008-00202
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER WENT TO THE CUSTOMER SITE AND DETERMINED THAT THE PROBE WAS BENT. REPLACEMENT OF THE PROBE HAS RETURNED THE INSTRUMENT TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROBE WAS BENT AND DRIPPING ON THE ORTHO PROVUE ANALYZER. THE CUSTOMER ALSO OBSERVED FLUID ON TOP OF THE GEL CARD FOIL. THE CUSTOMER ABORTED TESTING AND DISCONTINUED THE USE OF THE INSTRUMENT. NO ERRONEOUS RESULTS WERE REPORTED. PROBE DRIP MAY LEAD TO DILUTION OF SAMPLE/REAGENT, CARRY OVER AND/ OR CROSS CONTAMINATION AND ERRONEOUS RESULTS WHICH COULD 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