BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1053234 · Received May 28, 2008

    Report

    Report Number
    1056600-2008-00185
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 28, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE WAS DETERMINED. THE CUSTOMER CALLED BACK INDICATING THERE WAS CRACK ON THE CONNECTOR OF SOLUTION BOTTLE B. CUSTOMER WAS ADVISED TO ORDER A REPLACEMENT BOTTLE FROM THE PARTS DEPT. PART REPLACEMENT WILL RETURN 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

    ACCOUNT REPORTS THAT THEY FOUND FLUID UNDERNEATH THE WASTE BIN. ACCOUNT DOES NOT KNOW WHERE THE FLUID CAME FROM. THEY STATE THAT THEY RECEIVED NO ERROR MESSAGES. FLUID LEAK 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 SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1