BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1884928 · Received October 28, 2010

    Report

    Report Number
    1056600-2010-00129
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER ARRIVED AT THE CUSTOMER SITE AND REPLACED THE SYRINGE. THE FE PERFORMED THE ADJUSTMENT FOR THE PROBE TO THE INCUBATOR AND PRODUCED A NEW REFERENCE IMAGE. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PROVUE MISREAD A WEAK POSITIVE (1+) REACTION AS NEGATIVE USING THE DAT TEST ON A CORD SAMPLE. INCORRECT RESULTS WERE REPORTED. THE PHYSICIAN REQUESTED REPEAT TESTING USING MANUAL GEL METHOD SINCE THE RESULTS DID NOT MATCH THE PATIENTS MEDICAL DIAGNOSIS. DAT TESTING WAS REPEATED TWICE USING THE MANUAL GEL METHOD AND CONFIRMED TO BE POSITIVE (1+).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1