BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1133513 · Received August 21, 2008

    Report

    Report Number
    1056600-2008-00267
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    July 27, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER CONTACTED THE CUSTOMER. THE CUSTOMER INDICATED THEY DISCOVERED THAT THE HOSE CONNECTION TO THE WASTE BOTTLE WAS NOT CONNECTED PROPERLY RESULTING IN THE LEAKAGE. THE PROPER CONNECTION TO THE WASTE BOTTLE HAS RETURNED THE ANALYZER TO EXPECTED OPERATION. THE CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT. (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE ORTHO PROVUE ANALYZER WAS ATTEMPTING TO ASPIRATE REAGENTS DURING QC TESTING, THE PROBE LEAKED FLUID. REAGENT CONTAMINATION OCCURRED. THE CUSTOMER ABORTED QC TESTING AND NO PATIENT TESTING WAS PERFORMED. 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 SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1