BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ANALYZER GEL

    MDR report key: 21702251 · Received March 26, 2025

    Report

    Report Number
    2250051-2025-00016
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 19, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    UDI-DI
    10758750012817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DETAILS FROM WINDCHILL RA609373: ON 28FEB2025, GTSC ANALYZED THE DATA AVAILABLE USING ECONNECTIVITY DASHBOARD OF THE ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) AND FOUND THAT: - THE ORIGINAL GRADED RESULTS ARE MATCHING THE RESULTS ON THE ORDER REPORTS THAT WERE PROVIDED BY THE CUSTOMER BASED ON THE RESULTS REPORT TABLE - SAMPLE ID (B)(6) WITH ENCRYPTED ID OF C7-61-04-85-0F-C3-00-62-9C-46-5D-EF-14-71-36-A9- EB-34-3E-3A-09-C3-DB-AD-06-BE-F7-8B-B6-1B-68-8A WAS MANUALLY ASSIGNED AT 20:28 ON 27FEB2025 TO SRDR1 OUTER ROTOR, SLOT 2, POSITION 7 BASED ON THE EVENTS TABLE REPORT. ON 03MAR2025, GTSC FURTHER ANALYZED THE ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) COMMON LOGFILES COLLECTED BY THE ORTHO FIELD ENGINEER AND FOUND THAT: - BETWEEN 18:31 AND 21:01 ON (B)(6) 2025, SIX SPECIMEN TUBES SHOWED AN ERROR CODE SRDR80 (SAMPLE BARCODE CANNOT BE READ) USING THE CONDITION CODES TABLE. - PER BARCODE SCAN REPORT, IT IS UNDERSTOOD THAT THAT SAMPLE ID (B)(6) WAS POSITIONED IN POSITION 6 WHEREAS IT WAS ASSIGNED MANUALLY TO POSITION 7. THUS, IT IS CONCLUDED THAT THE DISCORDANT RESULTS IN ABO/RH ANTIGEN TYPING, ABO REVERSE TYPING AND ANTIBODY SCREENING OBTAINED BY THE CUSTOMER IS DUE TO A USER ERROR, THE CUSTOMER HAVING WRONGLY MANUALLY ASSIGNED THE PATIENT SAMPLE. NO FURTHER INVESTIGATION WAS CARRIED OUT ON THESE INCIDENTS. THE ASSIGNABLE CAUSE OF THE DISCORDANT RESULTS IN ABO/RH ANTIGEN TYPING, ABO REVERSE TYPING AND ANTIBODY SCREENING OBTAINED BY THE CUSTOMER IS A USE ERROR, THE CUSTOMER HAVING WRONGLY MANUALLY ASSIGNED THE PATIENT SAMPLE. THERE IS NO EVIDENCE OF ANY SYSTEMATIC FAILURE OF THE ORTHO ANALYZER TO PERFORM AS INTENDED. IN MITIGATION OF THE USE ERROR THE ORTHO VISION ID-MTS ANALYZER REFERENCE GUIDE STATES UNDER THE ASSIGN TO POSITION SECTION: DANGER: MISMATCHED SAMPLES, REAGENTS, OR DILUENTS MAY RESULT IN INCORRECT RESULTS. REMOVE THE APPROPRIATE RACK FROM THE LOAD STATION. ENTER THE SAMPLE ID, REAGENT ID, OR DILUENT ID IN THE APPROPRIATE FIELDS ON THE SCREEN, AS NEEDED. VERIFY ALL SAMPLE, REAGENT, OR DILUENT POSITIONS ARE CORRECT THROUGH THE SOFTWARE SCREEN DIAGRAM BEFORE STARTING SAMPLE PROCESSING. NO OTHER COMPLAINT OF THIS TYPE HAS BEEN RECEIVED FROM THE CUSTOMER SITE SINCE THE TIME OF THE REPORTED EVENTS.

    Description of Event or Problem · 0

    CMS (B)(4) WINDCHILL RA609373 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 TO REPORT DISCORDANT RESULTS IN ABO/RH ANTIGEN TYPING, ABO REVERSE TYPING AND ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) OBTAINED WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) EQUIPPED WITH SOFTWARE VERSION 5.16.0. COMPLAINANT/COMPLAINT REPORTER NAME AND POSITION: (B)(6), MEDICAL TECHNOLOGIST. EVENT DATE: 27FEB2025. REAGENTS: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 102524037-01 (EXPIRY DATE 28JUL2025, MANUFACTURE DATE 28OCT2024) MTS DILUENTS 2 PLUS LOT MDP244 (EXPIRY DATE 13AUG2025, MANUFACTURE DATE 13AUG2024) 0.8% AFFIRMAGEN LOT 8A884 (EXPIRY DATE 04MAR2025, MANUFACTURE DATE 17DEC2024) 0.8% SELECTOGEN LOT VS684 (EXPIRY DATE 18MAR2025, MANUFACTURE DATE 14JAN2025) MTS ANTI-IGG CARD LOT 092024001-11 (EXPIRY DATE 17JUL2025; MANUFACTURE DATE 17OCT2024). PATIENT INFORMATION: SAMPLE ID (B)(6); PATIENT ID(B)(6) 58-YEAR-OLD FEMALE. THE CUSTOMER REPORTED THAT ON (B)(6)2025, THEY TESTED SAMPLE ID (B)(6) FROM THIS PATIENT FOR ABO/RH ANTIGEN TYPING, ABO REVERSE TYPING AND ANTIBODY SCREENING IN IAT IN COMBINATION WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 102524037-01, MTS DILUENTS 2 PLUS LOT MDP244, 0.8% AFFIRMAGEN LOT 8A884, 0.8% SELECTOGEN LOT VS684 AND MTS ANTI-IGG CARD LOT 092024001-11 AND THAT THEY OBTAINED: BLOOD GROUP: O RHD NEGATIVE. ABO FORWARD AND REVERSE TESTS WERE CONCORDANT AT 20:46. ANTIBODY SCREENING: NEGATIVE REACTIONS WITH CELLS 1 AND 2 OF THE RED CELL REAGENTS AT 21:00. THE CUSTOMER REPORTED THAT THE CARD IMAGES PRODUCED BY THE ANALYZER ARE CONSISTENT WITH THE INTERPRETATION OF THE RESULTS PROVIDED BY THE ANALYZER SOFTWARE. THE CORRESPONDING ANALYZER ORDER REPORTS CONFIRMING THE ABOVE RESULTS WERE PROVIDED. THE CUSTOMER CLAIMED THAT WHILE TESTING THIS SAMPLE, THEY OBSERVED MULTIPLE ERROR CODES ON THE ANALYZER. HOWEVER, THE CUSTOMER WAS NOT SURE ABOUT THE ERROR CODES AND DESCRIPTIONS. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY RE-TESTED THE SAME PATIENT SAMPLE FOR ABO/RH ANTIGEN TYPING, ABO REVERSE TYPING AND ANTIBODY SCREENING IN IAT IN COMBINATION WITH THEIR ALTERNATE ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) USING THE SAME REAGENTS LOTS AND THAT THEY OBTAINED: BLOOD GROUP: A RHD POSITIVE. ABO FORWARD AND REVERSE TESTS WERE CONCORDANT AT 20:55. ANTIBODY SCREENING: A NEGATIVE REACTION WITH CELL 1 AND A 2+ REACTION WITH CELL 2 OF THE RED CELL REAGENT AT 21:11. THE CUSTOMER REPORTED THAT THE CARD IMAGES PRODUCED BY THE ANALYZER ARE CONSISTENT WITH THE INTERPRETATION OF THE RESULTS PROVIDED BY THE ANALYZER SOFTWARE. THE CORRESPONDING ANALYZER ORDER REPORTS CONFIRMING THE ABOVE RESULTS WERE PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY RE-TESTED THE SAME PATIENT SAMPLE USING MANUAL TUBE METHOD AND THAT THEY OBTAINED: BLOOD GROUP: A RHD POSITIVE. ABO FORWARD AND REVERSE TESTS WERE CONCORDANT. ANTIBODY SCREENING: A NEGATIVE REACTION WITH CELL 1 AND A POSITIVE REACTION WITH CELL 2 OF 0.8% SELECTOGEN LOT VS684. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT ON THE SAME DAY, THEY RE-TESTED THE SAME PATIENT SAMPLE FOR ABO/RH ANTIGEN TYPING, ABO REVERSE TYPING AND ANTIBODY SCREENING IN IAT IN COMBINATION WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) USING THE SAME REAGENTS LOTS AND THAT THEY OBTAINED: BLOOD GROUP: A RHD POSITIVE. ABO FORWARD AND REVERSE TESTS WERE CONCORDANT AT 21:57. ANTIBODY SCREENING: A NEGATIVE REACTION WITH CELL 1 AND A 2+ REACTION WITH CELL 2 AT 22:17. THE CUSTOMER REPORTED THAT THE CARD IMAGES PRODUCED BY THE ANALYZER ARE CONSISTENT WITH THE INTERPRETATION OF THE RESULTS PROVIDED BY THE ANALYZER SOFTWARE. THE CORRESPONDING ANALYZER ORDER REPORTS CONFIRMING THE ABOVE RESULTS WERE PROVIDED. THE CUSTOMER CONCLUDED THEREFORE THAT THE EXPECTED BLOOD GROUP AND ANTIBODY SCREENING OF THIS PATIENT IS A RHD POSITIVE AND ANTIBODY SCREENING POSITIVE. THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED BECAUSE OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700656 ORTHO VISION ANALYZER GEL AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750012817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown