BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 5454218 · Received February 23, 2016

    Report

    Report Number
    1056600-2016-00020
    Event Type
    Malfunction
    Date Received
    February 23, 2016
    Date of Event
    January 21, 2015
    Report Date
    February 23, 2016
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON (B)(6) 2016 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND PERFORMED MOD 41 PER CURRENT SERVICE CD TO RETURN THE BRIGHTNESS TO VALUE OF 124, WITH SPEC BEING 101-128. THE FE PERFORMED ALL MOD PROCEDURES AND ADJUSTMENTS LISTED IN THE MOD INSTRUCTIONS FOR THIS MODIFICATION. THE FE THEN RAN ALL 18 ITEMS OF DIAGNOSTICS SUCCESSFULLY. QUALITY CONTROL MATERIALS HAVE BEEN PROCESSED AND THE QC RESULTS HAVE BEEN VERIFIED AND ACCEPTED BY THE CUSTOMER. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE FE DISCOVERED THAT THE PROVUE CAMERA SETTING WAS OUT OF SPECIFICATION. THE LOG SHOWED THE SETTING TO BE AT 129 WHICH IS OUT OF SPECIFICATION (SPECIFICATION: 101-128) . THE CUSTOMER IS UNABLE TO CONFIRM NO ERRONEOUS RESULTS HAVE BEEN REPORTED DUE TO THE LENGTH OF TIME THE OUT OF SPECIFICATION CONDITION HAS EXISTED. THE FE INFORMED THE CUSTOMER OF THE OUT OF SPECIFICATION FINDING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111535 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1