BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS ANALYZER

    MDR report key: 15157296 · Received August 3, 2022

    Report

    Report Number
    2250051-2022-00050
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 27, 2022
    Report Date
    August 3, 2022
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MXP32181105 QERTS# (B)(4). EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS: (B)(6). E-CONNECTIVITY DATA AND THE RESULTS REPORTS FOR TESTING PERFORMED ON (B)(6) AND (B)(6) 2022 ON THE CUSTOMERS ORTHO VISION BIOVUE ANALYSER WAS REVIEWED BY ORTHO SECOND LEVEL AND IT WAS CONCLUDED THAT: SAMPLE ID #(B)(6) TESTED ON 27TH JULY AT 15:36 WITH PROFILE 'GRUPPOCOMPLETO' PROFILE GRUPPOCOMPLETO IS SETUP WITH 2 SEPARATE TESTS: - ABO(FWD)-D/CDE-44 WITH THE CONCLUSION A POS, ACCEPTED BY USER; -4 ABO(RVS)-A1,A2,B,O WITH THE CONCLUSION AB, ACCEPTED BY USER. THE SAME SAMPLE (SAMPLE ID #(B)(6)) WAS REPEATED AT 15:59 WITH PROFILE 'ABORHCOOMBSIND' THIS PROFILE IS ALSO COMPOSED BY 2 ABO TESTS: ABO(FWD)-D/CDE-44 WITH CONCLUSION A POS, ACCEPTED BY USER; -4 ABO(RVS)-A1,A2,B,O WITH CONCLUSION AB, ACCEPTED BY USER; + 4 ABSCR SUG POLY WITH A NEGATIVE CONCLUSION, ACCEPTED BY VISION. SAMPLE ID #4008730346 TESTED ON 28TH JULY AT 13:03 WITH PROFILE 'ABORHCOOMBSIND' -ABO(FWD)-D/CDE-44 WITH CONCLUSION A POS, ACCEPTED BY USER; -4 ABO(RVS)-A1,A2,B,O WITH CONCLUSION AB EDITED BY THE OPERATOR WITH B CELLS GIVING AN INDETERMINATE '?' GRADING, ACCEPTED BY USER; + 4 ABSCR SUG POLY WITH A NEG CONCLUSION, ACCEPTED BY VISION. WITH HAVING PROFILES SETUP WITH TWO DIFFERENT TEST SUCH AS 'ABO(FWD)-D/CDE-44' FOR THE ABO FORWARD GROUPING AND '4 ABO(RVS)-A1,A2,B,O' FOR THE ABO REVERSE GROUPING WITH THE OPTION VALID TEST RESULT INTERPRETATION BEING ON YES, THE ORTHO VISION BIOVUE ANALYSER DOES NOT AUTOMATICALLY ACCEPT THE RESULT BUT THE CONCLUSION OF EACH SEPARATED TEST MUST BE REVIEWED BY THE OPERATOR. IT IS POSSIBLE THAT BY MISTAKE THE OPERATOR ACCEPTED BOTH CONCLUSIONS WITH DIFFERENT ABO RESULTS WHICH WERE RELEASED TO LIS. TO AVOID AN OPERATOR RELEASING TWO DIFFERENT CONCLUSIONS FOR ABO FORWARD AND ABO REVERSE GROUPING IN ERROR, A COMBINED TEST CAN BE USED SUCH AS '4 ABO(FWD)-D/CDE-44 + (RVS)-A1,A2,B,O' WHICH WILL PERFORM THE SAME TESTING BUT WITH A SINGLE ABO CONCLUSION AND IN THE CASE OF A DISCREPANCY ACCEPTED BY MISTAKE BY THE OPERATOR, THE CONCLUSION SENT WILL BE INDETERMINATE. THEREFORE THE ORTHO VISION BIOVUE ANALYSER WOULD HAVE SUBMITTED THEM SEPARATELY TO THE LIS AFTER THE LABORATORY OPERATOR MANUALLY CONFIRMED THE RESULT. THE ASSIGNABLE CAUSE OF THE DISCREPANT RESULT FOR ABO REVERSE GROUPING BEING SENT TO THEIR LABORATORY INFORMATION SYSTEM (LIS) IS USE ERROR RELATED, THE CUSTOMER ACCEPTING A DISCREPANT RESULT. THE ANALYSER IS PERFORMING AS PER DESIGN. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. THERE WAS NO REPORT OF PATIENT HARM. THE CUSTOMER HAS NOT SINCE REPORTED A SIMILAR EVENT SINCE THE TIME OF THE REPORTED EVENT. -FOR REPORTING PURPOSES, ORTHO CURRENTLY CONSIDERS THE ORTHO BIOVUE VISION¿/ VISION¿ MAX ANALYZERS TO BE A SIMILAR PRODUCT TO THE FDA CLEARED ORTHO ID-MTS VISION¿/ VISION¿MAX ANALYZERS AND THEREFORE, THE EVENT IS REPORTABLE TO THE FDA. IN SUMMARY: INCORRECT RESULT FOR ABO REVERSE TYPING SENT TO THE LABORATORY INFORMATION SYSTEM (LIS). THE ASSIGNABLE CAUSE OF THE INCORRECT RESULT BEING SENT AUTOMATICALLY TO LIS IS USE ERROR, THE CUSTOMER CONFIRMING A DISCREPANT RESULT. ANALYSER IS PERFORMING AS PER DESIGN. NO GENERAL PRODUCT FAILURE WAS IDENTIFIED. A BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER COMPLAINED TO ORTHOCARE AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT ABO REVERSE RESULTS BEING SENT AUTOMATICALLY TO THEIR LABORATORY INFORMATION SYSTEM (LIS) FROM THEIR ORTHO VISION BIOVUE ANALYSER (J60002642 EQUIPPED WITH SOFTWARE VERSION 5.13.4). COMPLAINANT/COMPLAINT REPORTER: (B)(6) - PHYSICIAN. DATE OF EVENTS: (B)(6) AND (B)(6) 2022. REPORTED ON: 28 JULY 2022 BY (B)(6) TO THE ORTHOCARE HELPDESK. SOFTWARE VERSION: 5.13.4. PATIENT INFORMATION: SAMPLE ID #(B)(6). THE CUSTOMER REPORTED THAT ON (B)(6) 2022, THEY HAD TESTED A PATIENT SAMPLE FOR ABO GROUPING AND THAT THEY HAD OBTAINED A BLOOD GROUP A(ABO1) RESULT (EXPECTED RESULT) IN FORWARD GROUPING AND A BLOOD GROUP AB(ABO3) RESULT (INCORRECT RESULT) IN THE REVERSE GROUP DETERMINATION (INVESTIGATED UNDER CMS #(B)(4) CI #(B)(4)). THE CUSTOMER STATED THAT THE LABORATORY OPERATOR HAD ACCEPTED BOTH THE FORWARD AND REVERSE RESULTS WHICH WERE BOTH SENT TO THE LIS HOWEVER THE LIS HAD CONCLUDED AB(ABO3) BLOOD GROUPING RESULT FOR THIS PATIENT. THE CUSTOMER REPORTED THAT ON (B)(6) 2022, AS PART OF THE TROUBLESHOOTING, THEY RETESTED THE SAME PATIENT SAMPLE FOR ABO FORWARD AND REVERSE GROUPING AND THE DISCREPANCIES BETWEEN BOTH TESTS WERE SENT AGAIN TO THEIR LIS. THE CUSTOMER WAS ABLE TO REPRODUCE THE ISSUE. NO FURTHER DETAIL PROVIDED. THE CUSTOMER CONFIRMED THAT A BIASED AB(ABO3) BLOOD GROUPING RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951785 ORTHO VISION ID-MTS ANALYZER AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown