BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA EFLEXIS

    MDR report key: 19905964 · Received August 5, 2024

    Report

    Report Number
    3002772505-2024-00003
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 12, 2024
    Report Date
    July 12, 2024
    Manufacturer
    DIAGNOSTIC GRIFOLS S.A.
    Product Code
    KSZ
    PMA / PMN Number
    BK170130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) HOSPITAL REPORTED ON THE (B)(6) 2024 DIFFERENT PROBLEMS IN THE TEST ASSIGNMENT. A CROSSMATCH TEST WAS EXECUTED, BUT RESULTS WERE NOT DISPLAYED BECAUSE THEY WERE INCORRECTLY ASSIGNED TO ANOTHER RECIPIENT. THE MANUFACTURER INVESTIGATION DETERMINED THAT THE ANALYZER HAS THE POTENTIAL TO ASSIGN INCORRECT CROSSMATCH RESULTS WHEN THE 'DUPLICATE THE RECIPIENT-DONOR PROFILE ASSIGNMENT' FEATURE IS USED. AN INCORRECT ASSIGNMENT OF RESULTS COULD LEAD TO A SERIOUS INCIDENT IF A TRANSFUSION WOULD BE PERFORMED BASED ON THE INCORRECT RESULTS. IN THIS CASE, THE ISSUE DID NOT IMPLY THE TRANSFUSION OF UNSUITABLE BLOOD PRODUCT AS THE CUSTOMER WAS UNABLE TO VIEW THE RESULT WITH THE EXPECTED RECIPIENT AND DONOR COMBINATION. THE 'DUPLICATE THE RECIPIENT-DONOR PROFILE ASSIGNMENT' FEATURE IS ACCESSIBLE FROM WITHIN THE DONOR ASSIGNMENT BUTTON. THIS MANUAL FEATURE ALLOWS THE OPERATOR TO DUPLICATE THE RECIPIENT - DONOR(S) ASSIGNMENT, FOR THE PURPOSE OF RE-ASSIGNING THE SAME DONOR AND OPTIONALLY ADDING NEW ONES TO A DIFFERENT RECIPIENT. WHEN THIS RECIPIENT IS MODIFIED AND THE NEW PROFILE IS QUEUED THIS PROFILE IS NOT EXECUTED AND THE RESULTS OF THE INITIAL RECIPIENT ARE INCORRECTLY ASSIGNED TO THIS NEW RECIPIENT AND REMOVED FROM THE INITIAL ONE. CROSSMATCH TESTING EXECUTED FROM A LIS REQUEST OR ANY OTHER MANUAL ASSIGNATION METHOD ARE NOT AFFECTED. THE ERROR CAN ONLY ARISE WHEN THE 'DUPLICATE THE RECIPIENT-DONOR PROFILE ASSIGNMENT' FEATURE IS USED TO DUPLICATE A CROSSMATCH TEST WHICH IS EITHER IN "PENDING_TO_VALIDATE", "VALIDATED" OR "EXPORTED" STATUS. IF THE CROSSMATCH RESULTS OF THE FIRST RECIPIENT ARE EXPORTED AND THE FIRST RECIPIENT IS NO LONGER AVAILABLE ON THE INSTRUMENT, THE ERROR DOES NOT OCCUR. THE PROBABILITY OF AN INCORRECT ASSIGNMENT OF RESULTS IN A CROSSMATCH TEST IS VERY LOW AS IT IS UNUSUAL FOR A CROSSMATCH TEST RESULT TO REMAIN IN THE "PENDING_TO_VALIDATE" OR "VALIDATED" STATUS FOR AN EXTENDED PERIOD OF TIME, ESPECIALLY FOR CUSTOMERS UTILIZING THE AUTO-VALIDATION AND AUTO-EXPORTATION FUNCTIONS. ADDITIONALLY, THE USE OF 'DUPLICATE RECIPIENT-DONOR PROFILE ASSIGNMENT' FEATURE IS CONSIDERED A MINOR FEATURE BECAUSE CROSSMATCHING THE SAME DONORS TO DIFFERENT RECIPIENTS OCCURS INFREQUENTLY. THIS REMOTE PROBABILITY IS FURTHER SUPPORTED BY THE FACT THAT THE ERROR COULD OCCUR IN SOFTWARE VERSIONS THAT HAVE BEEN INSTALLED IN THE MARKET FOR 6 YEARS AND THE ERROR HAS NEVER BEEN REPORTED. THIS ERROR WAS DETECTED ANALYZING A CUSTOMER COMPLAINT, WHICH REPORTED THAT CROSSMATCH RESULTS WERE NOT AVAILABLE. FINALLY, IT IS NOTEWORTHY THAT THE ISSUE IS LIKELY DETECTABLE BECAUSE THE CUSTOMER WILL BE MISSING RESULTS FROM A CROSSMATCH THAT WAS PERFORMED. THE INVESTIGATION SHOWS THAT THIS ERROR CAN OCCUR IN VERSIONS 1.2.0 TO 3.1.0. THE SOURCE OF THE ERROR AFFECTING THIS FEATURE IS ALREADY RESOLVED IN SOFTWARE VERSION 3.2.0.

    Description of Event or Problem · 0

    (B)(6) HOSPITAL REPORTED ON THE 12 JUL 24 DIFFERENT PROBLEMS IN THE TEST ASSIGNMENT. A CROSSMATCH TEST WAS EXECUTED, BUT RESULTS WERE NOT DISPLAYED BECAUSE THEY WERE INCORRECTLY ASSIGNED TO ANOTHER RECIPIENT. THE MANUFACTURER INVESTIGATION DETERMINED THAT THE ANALYZER HAS THE POTENTIAL TO ASSIGN INCORRECT CROSSMATCH RESULTS WHEN THE 'DUPLICATE THE RECIPIENT-DONOR PROFILE ASSIGNMENT' FEATURE IS USED. AN INCORRECT ASSIGNMENT OF RESULTS COULD LEAD TO A SERIOUS INCIDENT IF A TRANSFUSION WOULD BE PERFORMED BASED ON THE INCORRECT RESULTS. IN THIS CASE, THE ISSUE DID NOT IMPLY THE TRANSFUSION OF UNSUITABLE BLOOD PRODUCT AS THE CUSTOMER WAS UNABLE TO VIEW THE RESULT WITH THE EXPECTED RECIPIENT AND DONOR COMBINATION. THE 'DUPLICATE THE RECIPIENT-DONOR PROFILE ASSIGNMENT' FEATURE IS ACCESSIBLE FROM WITHIN THE DONOR ASSIGNMENT BUTTON. THIS MANUAL FEATURE ALLOWS THE OPERATOR TO DUPLICATE THE RECIPIENT - DONOR(S) ASSIGNMENT, FOR THE PURPOSE OF RE-ASSIGNING THE SAME DONOR AND OPTIONALLY ADDING NEW ONES TO A DIFFERENT RECIPIENT. WHEN THIS RECIPIENT IS MODIFIED AND THE NEW PROFILE IS QUEUED THIS PROFILE IS NOT EXECUTED AND THE RESULTS OF THE INITIAL RECIPIENT ARE INCORRECTLY ASSIGNED TO THIS NEW RECIPIENT AND REMOVED FROM THE INITIAL ONE. CROSSMATCH TESTING EXECUTED FROM A LIS REQUEST OR ANY OTHER MANUAL ASSIGNATION METHOD ARE NOT AFFECTED. THE ERROR CAN ONLY ARISE WHEN THE 'DUPLICATE THE RECIPIENT-DONOR PROFILE ASSIGNMENT' FEATURE IS USED TO DUPLICATE A CROSSMATCH TEST WHICH IS EITHER IN "PENDING_TO_VALIDATE", "VALIDATED" OR "EXPORTED" STATUS. IF THE CROSSMATCH RESULTS OF THE FIRST RECIPIENT ARE EXPORTED AND THE FIRST RECIPIENT IS NO LONGER AVAILABLE ON THE INSTRUMENT, THE ERROR DOES NOT OCCUR. THE PROBABILITY OF AN INCORRECT ASSIGNMENT OF RESULTS IN A CROSSMATCH TEST IS VERY LOW AS IT IS UNUSUAL FOR A CROSSMATCH TEST RESULT TO REMAIN IN THE "PENDING_TO_VALIDATE" OR "VALIDATED" STATUS FOR AN EXTENDED PERIOD OF TIME, ESPECIALLY FOR CUSTOMERS UTILIZING THE AUTO-VALIDATION AND AUTO-EXPORTATION FUNCTIONS. ADDITIONALLY, THE USE OF 'DUPLICATE RECIPIENT-DONOR PROFILE ASSIGNMENT' FEATURE IS CONSIDERED A MINOR FEATURE BECAUSE CROSSMATCHING THE SAME DONORS TO DIFFERENT RECIPIENTS OCCURS INFREQUENTLY. THIS REMOTE PROBABILITY IS FURTHER SUPPORTED BY THE FACT THAT THE ERROR COULD OCCUR IN SOFTWARE VERSIONS THAT HAVE BEEN INSTALLED IN THE MARKET FOR 6 YEARS AND THE ERROR HAS NEVER BEEN REPORTED. THIS ERROR WAS DETECTED ANALYZING A CUSTOMER COMPLAINT, WHICH REPORTED THAT CROSSMATCH RESULTS WERE NOT AVAILABLE. FINALLY, IT IS NOTEWORTHY THAT THE ISSUE IS LIKELY DETECTABLE BECAUSE THE CUSTOMER WILL BE MISSING RESULTS FROM A CROSSMATCH THAT WAS PERFORMED. IF THE INCORRECT ASSIGNATION OF RESULTS WERE TO OCCUR, THE PROBABILITY OF THIS LEADING TO HARM TO A PATIENT IS ALSO VERY LOW. AS STATED IN THE STANDARDS FOR BLOOD BANKS AND TRANSFUSION SERVICES PUBLISHED BY THE AABB (1) 'PRETRANSFUSION TESTS FOR ALLOGENEIC TRANSFUSION SHALL INCLUDE ABO GROUP AND RH TYPE. IN ADDITION, FOR WHOLE BLOOD, RED BLOOD CELL, AND GRANULOCYTE COMPONENTS, PRETRANSFUSION TESTING FOR UNEXPECTED ANTIBODIES TO RED CELL ANTIGENS SHALL BE PERFORMED.' IN THE CASE THAT A DISCREPANCY WAS IDENTIFIED BETWEEN THE PRE-TRANSFUSION TESTS PERFORMED, THE DISCREPANCY WOULD NEED TO BE RESOLVED PRIOR TO PERFORMING A TRANSFUSION OF A BLOOD PRODUCT. THEREFORE, NO HARM WOULD COME TO THE PATIENT. THE INVESTIGATION SHOWS THAT THIS ERROR CAN OCCUR IN VERSIONS 1.2.0 TO 3.1.0. THE SOURCE OF THE ERROR AFFECTING THIS FEATURE IS ALREADY RESOLVED IN SOFTWARE VERSION 3.2.0. (1) STANDARDS FOR BLOOD BANKS AND TRANSFUSION SERVICES, AABB, 30TH EDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026970 ERYTRA EFLEXIS ERYTRA EFLEXIS KSZ DIAGNOSTIC GRIFOLS S.A. DG-511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other