BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1040408 · Received May 7, 2008

    Report

    Report Number
    1056600-2008-00144
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 7, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. THE CUSTOMER HAD PLACED A SAMPLE TUBE ON BOARD THE ANALYZER WITH THE CAP/STOPPER ON, WHICH LED TO A BENT PROBE AND THE PROBE DRIP. AN OCD FIELD ENGINEER VISITED THE CUSTOMER SITE AND REPLACED THE PROBE AND PERFORMED THE APPROPRIATE ADJUSTMENTS TO RETURN THE ANALYZER TO EXPECTED OPERATION. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SAMPLE CAP WAS INADVERTENTLY LEFT ON THE SAMPLE TUBE ON THE ORTHO PROVUE ANALYZER, RESULTING IN A BENT PROBE AND PROBE DRIP. THE CUSTOMER INDICATED THAT THEY DID NOT OBSERVE REAGENT OR SAMPLE CONTAMINATION. THE CUSTOMER ABORTED TESTING. 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

    Patients

    Seq Age Sex Outcome Treatment
    1