BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION

    MDR report key: 8790339 · Received July 15, 2019

    Report

    Report Number
    2250051-2019-00034
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 15, 2019
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE DESCRIBED IS RELATED TO A KNOWN OCCURRENCE IN WHICH THE VISION QC SOFTWARE ALLOWS THE USERS TO MODIFY THEIR QC SETTING UNDER RUN QC JOB OVERRIDING WHAT HAS BEEN ESTABLISHED IN QC SET UP. THIS ISSUE IS BEING ADDRESSED IN FUTURE SOFTWARE VERSIONS UNDER TFS CHANGE REQUEST (B)(4). CUSTOMER HAS RECEIVED THE NEW SOFTWARE. NO INCORRECT OR ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THIS INCIDENT. THERE WAS NO RISK PRESENT AT THE TIME OF THE INCIDENT. THERE WAS NO HARM TO ANY PATIENT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED TSC TO REPORT UNEXPECTED QUALITY CONTROL SAMPLE ID CONFIGURATIONS AT THE COMPLETION OF QC TESTING ALTHOUGH QC IS LISTED AS "PASS." CUSTOMER REPORTS THE ORTHO VISION SOFTWARE ALLOWED USERS ON (B)(6) 2019 TO MODIFY THEIR ALBA QC SAMPLES IDS UNDER RUN QC JOB WHILE NOT ALERTING THE USER IF THESE MODIFICATIONS ARE INCONSISTENT WITH THE SETUP CONFIGURATION. AT THAT TIME CUSTOMER WAS ON PREVIOUS (B)(4). THE FOLLOWING PROFILES WERE MODIFIED INCORRECTLY; ABSC AND ABD DONOR. CUSTOMER WAS IN THE PROCESS OF ENTERING NEW LOT OF ALBA Q QC WHEN ERROR WAS ENCOUNTERED. TROUBLESHOOTING STEPS REQUESTED BY TSC: TSC CHECKED ECONN VISION OPERATIONS REPORTS / QC EVENTS -RAW AND CONFIRMED QC WAS SETUP INCORRECTLY. CUSTOMER REPORTS ABD DONOR TESTS WERE PERFORMED ON CORD SAMPLES. ABD DONOR PROFILE ONLY QC1 (VIAL# (B)(6)) A NEG WAS RUN. ABSC PROFILE ONLY QC1((B)(6)) POS SCREEN WAS RUN. TSC EXPLAINED CONFIGURATION OF SOFTWARE AND SAFEGUARDS/BEST PRACTICES IN ORDER TO CHANGE QC SAMPLES SUCCESSFULLY WITHOUT DELETIONS OR INCORRECT INSERTIONS. TSC ALSO REFERRED CUSTOMER TO QUALITY CONTROL SECTION OF THE EDITABLE SELF SERVICE CUSTOMER PROCEDURE GUIDE(S) (J56102, 2016-04-26). CUSTOMER HAS CONFIRMED SHE HAS TAKEN CORRECTIVE STEPS NECESSARY ON THE VISION SOFTWARE TO RECTIFY THE CONCERN. CUSTOMER WILL DISCUSS EVENT WITH MEDICAL DIRECTOR AS RESULTS WERE RELEASED WITHOUT VALID CONTROLS BEING RUN. CUSTOMER HAS SINCE THEN UPGRADED SW VERSION TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581520 ORTHO VISION AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ

    Patients

    Seq Age Sex Outcome Treatment
    1