BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3530760 · Received December 20, 2013

    Report

    Report Number
    1056600-2013-00077
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 26, 2013
    Report Date
    December 20, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE. THE FE IMMEDIATELY RAN THE COMPLETE DIAGNOSTICS TEST. THE DIAGNOSTIC TEST PASSED COMPLETELY IN ALL PHASES. THE FE VERIFIED AND ADJUSTED THE GEL READER CAMERA, THEN RERAN THE COMPLETE DIAGNOSTIC. THE DIAGNOSTIC TEST AGAIN PASSED ALL PHASES OF THE TEST. THE CUSTOMER RAN CONTROLS ON TESTS THAT ARE PROCESSED ON THIS PROVUE ANALYZER AND VERIFIED THAT ALL THE CONTROL RESULTS ARE WITHIN THE LAB ESTABLISHED QC RANGES AND THAT NO MISREADING OF THE GEL CARDS OCCURRED. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE ORTHO PROVUE RESULTED AN AB POS IN THE FORWARD GROUP TEST FOR A SAMPLE THAT WAS A POS IN THE TUBE METHOD. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669524 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1