BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 6923950 · Received October 6, 2017

    Report

    Report Number
    1056600-2017-00086
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 25, 2017
    Report Date
    October 6, 2017
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON 9-26-17 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND WENT THROUGH AND PERFORMED THE GRIPPER AND CAMERA ADJUSTMENTS. THE FE CREATED A NEW REFERENCE IMAGE AND VERIFIED THE VISIO BRILLO BRIGHTNESS IS 119 WHICH IS WITH IN SPECIFICATION OF 101-128. THE FE ALSO COMPLETE A PM IN ACCORDANCE WITH THE CURRENT SERVICE CD GUIDELINES AND PM INSTRUCTIONS. THE CUSTOMER RAN CONTROLS AND HAS ACCEPTED QC, PM, AND REPAIRS. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE PROVUE MISREAD A 1+ REACTION AS NEGATIVE FOR ONE PATIENT SAMPLE THAT WAS CLEARLY POSITIVE UPON VISUAL REVIEW. NO INCORRECT RESULTS WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705545 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1