BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE ANALYZER

    MDR report key: 792310 · Received November 30, 2006

    Report

    Report Number
    1056600-2006-00351
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    November 7, 2005
    Report Date
    November 30, 2006
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK030023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY HAD OBSERVED FLUID DRIP FROM THE PROBE OF THE ORTHO PROVUE ANALYZER. AN OCD FIELD ENGINEER (FE) ARRIVED ON SITE. THE FE PERFORMED REPAIRS AND THE APPROPRIATE ADJUSTMENTS TO RETURN THE ANALYZER TO EXPECTED OPERATION. THE ANALYZER IS DESIGNED TO COMPLETE ITS TESTING CYCLE AND IN THE EVENT OF A NON-DISPENSE INCIDENT, POST A CONDITION CODE FOR EMPTY MICROTUBE (<>), WHICH ALERTS THE USER TO REVIEW THE ISSUE AND POSTS AN NRD (NO RESULT DETERMINED) PREVENTING ANY RESULT FROM BEING REPORTED. HOWEVER, IN THIS CASE, INFO WAS NOT PROVIDED REGARDING TESTING PERFORMED ON THE ANALYZER AND POSSIBLE ERROR CODES POSTED. ERRONEOUS RESULTS WERE NOT REPORTED. HOWEVER, IF THIS INCIDENT WERE TO RECUR UNDETECTED, ERRONEOUS RESULTS MAY OCCUR. BASED ON THE AVAILABLE INFO, INSTRUMENT MALFUNCTION CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR PROVUE IS NOT PIPETTING PLASMA INTO CARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE ANALYZER AUTOMATED BLOOD GROUPING AND ANTIBODY TE KSZ MICRO TYPING SYSTEMS, INC. MTS213784 2.15

    Patients

    Seq Age Sex Outcome Treatment
    1 *