BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3802673 · Received May 9, 2014

    Report

    Report Number
    1056600-2014-00027
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON (B)(4) 2014 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE. THE FE PERFORMED ALL ALIGNMENTS ON THE READER CAMERA AS PER SERVICE MANUAL. THE CUSTOMER RAN AND PASSED QC. THE CUSTOMER WAS ABLE TO GET A VALID READING BOTH MANUALLY AND WITH THE PROVUE ANALYZER AFTER THE REPAIR. ON (B)(4) 2014 AN OCD FIELD ENGINEER (FE) TELEPHONED THE CUSTOMER FOR FOLLOW UP ON PREVIOUS SERVICE VISIT. THE CUSTOMER STATES THAT THE PROVUE IS RUNNING AS EXPECTED WITH NO FURTHER ISSUES. REPAIRS HAVE RETURNED THIS UNIT TO EXPECTED OPERATIONS.

    Description of Event or Problem · 1

    THE PROVUE GAVE A NEGATIVE RESULT FOR A SAMPLE THAT HAD A PASSIVE ANTI-D IN ANTIBODY IDENTIFICATION TESTING. NO ERRONEOUS RESULTS WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280918 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1