BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 12128230 · Received July 7, 2021

    Report

    Report Number
    2250051-2021-00047
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 18, 2021
    Report Date
    July 7, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNEXPECTED DISPLAY AND PRINTING OF UDP TEST NAMES USING ORTHO VISION BIOVUE ANALYSERS. POTENTIAL RISK OF USING INCORRECT COMPATIBLE CROSS-MATCH RESULTS. THE ROOT-CAUSE OF THE ISSUE REPORTED BY THE CUSTOMERS IS NOT YET DETERMINED. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. NO PATIENT WAS HARMED. (B)(4).

    Description of Event or Problem · 0

    EVENT 1 OF 2 (TWO VISIONS IMPLICATED). A CUSTOMER COMPLAINED ABOUT WHAT WAS DESCRIBED AS UNEXPECTED DISPLAY AND PRINTING OF UDP TEST NAMES USING THEIR ORTHO VISION BIOVUE ANALYSERS. THE INITIAL CASE WAS REPORTED BY ANOTHER CUSTOMER FROM THE SAME COUNTRY AND INVESTIGATED UNDER (B)(4). COMPLAINANT: (B)(6) - HEAD OF LABORATORY. COMPLAINT REPORTER: MR. (B)(6) ¿ ORTHO LABORATORY SPECIALIST. DATES OF EVENTS: NOT PROVIDED. REPORTED ON: (B)(6) 2021 BY MR. (B)(6) WHO REPORTED IT TO THE ORTHOCARE HELPDESK ON THE SAME DAY. SOFTWARE VERSION: 5.12.8. REAGENTS: NOT APPLICABLE. PATIENT/ DONOR INFORMATION: NOT APPLICABLE. THE COMPLAINT REPORTER STATED THAT THIS EVENT IS THE SAME EVENT AS DESCRIBED IN (B)(4) BUT NO DETAILED DESCRIPTION WAS PROVIDED. ISSUE DESCRIBED BY FIRST CUSTOMER (B)(4) WAS THAT THEY ARE USING USER DEFINE PROFILES (UDP) TO PERFORM TESTING ON THEIR ORTHO VISION BIOVUE ANALYSER AND THAT THEY HAVE OBSERVED THE FOLLOWING. FOR UDP_ABD TUI MAU (ENGLISH TRANSLATION: DONOR ABD): IN THE USER DEFINED PROTOCOL OVERVIEW, THE EXPECTED RESULT DISPLAY IS ABO, RH, AS EXPECTED. THIS UDP HAS BEEN INCLUDED IN PROFILE PHAT HC (ENGLISH TRANSLATION: CROSSMATCH FOR RED CELL TRANSFUSION) WHICH INCLUDES THE FOLLOWING TESTS: ABD CONF-10, 4 MAJ XM IGG, UDP_ABD TUI MAU. WHEN THEY HAD RUN THE PROFILE PHAT HC FOR PATIENT AND DONOR'S SAMPLE, THEY REPORTED THAT: THE NAME OF THE TESTS WHICH ARE EXPECTED TO BE DISPLAYED AS ABO AND RH RESULTS FOR THE DONOR ARE INCORRECTLY PRESENTED AS XM AND XM; THE ABO AND RH RESULTS DISPLAYED ARE CORRECT; THE CROSSMATCH TEST IS DISPLAYED AS XM AS EXPECTED AND A CMP (COMPATIBLE RESULT) IS DISPLAYED. THE CUSTOMER REPORTED THAT THEY OBSERVED ALSO THAT ON THE PRINTED LAB REPORT, XM TEST NAME IS PRINTED INSTEAD OF ABO AND RH TEST NAMES FOR THE DONOR TESTED TOGETHER WITH THIS PATIENT. THE CORRESPONDING RESULTS ARE CORRECTLY PRINTED. THE CUSTOMER ALSO REPORTED THAT FOR THE RESULTS UPLOADED TO THE LIS FOR THESE PATIENT/ DONOR, WHERE THE NAME OF TEST SHOULD READ ABO AND RH FOR THE DONOR, THE DONOR ID WAS PRESENTED. NO FURTHER DETAIL WAS PROVIDED IF THE LIS WAS ABLE TO CORRECTLY INTEGRATE THE RECEIVED INFORMATION. THE CUSTOMER REPORTED THAT THE RESULTS OBTAINED WITH THEIR ANALYZER WERE ACCURATE. HOWEVER, THE CUSTOMER STATED THAT THE RHD RESULT THAT IS INCORRECTLY PRESENTED AS XM COULD BE USED AS AN XM RESULT AND REPORTED TO A PHYSICIAN. IF THE RHD RESULT IS NEGATIVE AND THE XM TEST PERFORMED IS POSITIVE, AN ERRONEOUS NEGATIVE/ COMPATIBLE XM RESULT COULD BE REPORTED TO THE PHYSICIAN AND INCOMPATIBLE BLOOD COULD BE TRANSFUSED TO A PATIENT. THE CUSTOMER REPORTED THEY HAD STOPPED USING THIS UDP PROFILE ON THEIR ORTHO VISION BIOVUE ANALYSER AND STARTED MANUAL TUBE TEST FOR DONOR TYPING. THE CUSTOMER REPORTED THAT NO PATIENT WAS HARMED AS A RESULT OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024046 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1