BEUDAMED
    FDA Adverse Event Death Summary report: N

    0.8% SURG 3X10ML

    MDR report key: 16214233 · Received January 20, 2023

    Report

    Report Number
    0002250051-2023-00036
    Event Type
    Death
    Date Received
    January 20, 2023
    Date of Event
    December 25, 2022
    Report Date
    January 20, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    QHT
    UDI-DI
    10758750007660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED DISCREPANT NEGATIVE ANTIBODY SCREENING RESULT FOR 1 PATIENT HAVING AN ANTI-K(KEL1) ANTIBODY. THE ASSIGNED CAUSE OF THE ALLEGED DISCREPANT NEGATIVE ANTIBODY SCREENING RESULT WAS DUE TO A HUMAN ERROR. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. A BIASED RESULT WAS REPORTED TO THE PHYSICIAN. HEALTH EFFECT-CLINICAL CODE: CODE 4581 USED (APPROPRIATE CODE NOT AVAILABLE). NEED TERM FOR TRANSFUSION REACTION AND PATIENT DEATH THE PATIENT EXPERIENCED A TRANSFUSION REACTION AND EXPIRED.

    Description of Event or Problem · 0

    (B)(4) INVESTIGATION: AS PART OF THE INVESTIGATION, RETAIN TESTING FOR VSS420, BATCH RECORD REVIEW AND COMPLAINT REVIEW WERE PERFORMED. ALL RESULTS MET CRITERIA AND ORTHO WAS UNABLE TO REPRODUCE THE EVENT. AN ORTHO FIELD ENGINEER WENT ON SITE ON (B)(4) 2022, PERFORMED THE FOLLOWING CHECKS - INCUBATOR, CENTRIFUGE AND FLUIDIC SYSTEM - AND CONFIRMED THE ANALYZER WAS WORKING AS INTENDED. AN ORTHO 2ND LEVEL PERSONNEL WENT ON SITE ON (B)(4) 2023 TO: COLLECT INFORMATION FROM THE CUSTOMER AND INTERNAL REPORTS TO INSPECT THE SAMPLES PROVIDED BY THE CUSTOMER (FOR THIS ISSUE AND THAT OF CMS (B)(4)) -TO RUN QC THAT PASSED -TO PULL LABORATORY INFORMATION SYSTEM LOGS FILES, COMMON LOGS (UPLOADED TO AXEDA) AND SCREENSHOTS FROM THE ANALYZER SETTINGS CONFIGURATION. FURTHER INVESTIGATION WAS PERFORMED BY ORTHO 2ND LEVEL. THREE DOCUMENTS WERE CREATED BY ORTHO PERSONNEL AND WERE SHARED WITH THE CUSTOMER DURING A CONFERENCE CALL THAT WAS HELD ON (B)(6) 2023. THESE DOCUMENTS SUMMARIZE THE TIMELINE AND SEQUENCE OF THE 2 EVENTS IN QUESTION (CMS (B)(4)) AS ORTHO UNDERSTAND THEM. THEY WERE DEVELOPED FROM VARIOUS SOURCES OF DATA, WHICH INCLUDE BUT NOT LIMITED TO INFORMATION IN THE COMPLAINT FILES, INFORMATION FROM CUSTOMER AND INTERNAL REPORTS, INFORMATION FROM E-CONNECTIVITY ANALYSIS AND A SITE VISIT BY 2ND LEVEL PERSONNEL. FINDINGS/HYPOTHESIS: SAMPLE ID (B)(6) WAS TESTED TWICE FOR ANTIBODY SCREENING IN IAT USING 0.8% SURGISCREEN LOT VSS420 AND A 3+ REACTION WAS OBTAINED WITH CELL 1 IN THE INITIAL TESTING (NEGATIVE IN THE REPEAT TESTING); THE POSITIVE ANTIBODY SCREENING WAS AUTOMATICALLY SENT TO THE CUSTOMER LABORATORY INFORMATION SYSTEM AND MANUALLY ARCHIVED AT THE ANALYZER LEVEL -RE-USE OF BARCODE LABELS FOR DIFFERENT PATIENT SAMPLES -INCONSISTENCIES FOR SAMPLE VOLUMES IN SAMPLE CONTAINERS BETWEEN THE DIFFERENT TESTS PERFORMED -MANUAL ENTRIES OF SAMPLE BARCODES IN SOME INSTANCES -ORDERS MANUALLY CREATED WHEREAS NO PENDING ORDERS FROM THE LIS -INCONSISTENT PLASMA APPEARANCE (COLOR) IN SAMPLE CONTAINERS BETWEEN THE DIFFERENT TESTS PERFORMED. ALTHOUGH A DEFINITIVE ASSIGNABLE CAUSE OF THE DISCREPANT NEGATIVE ANTIBODY SCREENING TEST COULD NOT BE DETERMINED, IT IS SPECULATED THAT SAMPLE PROCESSING AND TESTING ERRORS THAT OCCURRED AT THE CUSTOMER FACILITY ARE THE CAUSE OF THE DISCREPANCY. THE CUSTOMER IS WORKING WITH THEIR RISK MANAGEMENT SINCE AFTER ALL OF THE INVESTIGATIONS CONDUCTED BY ORTHO AND THEMSELVES, THE ROOT CAUSE OF THE ALLEGED DISCREPANT NEGATIVE ANTIBODY SCREENING RESULT WAS DUE TO A HUMAN ERROR. CUSTOMER REPORTED DISCREPANT NEGATIVE ANTIBODY SCREENING RESULT FOR 1 PATIENT HAVING AN ANTI-K(KEL1) ANTIBODY. THE ASSIGNED CAUSE OF THE ALLEGED DISCREPANT NEGATIVE ANTIBODY SCREENING RESULT WAS DUE TO A HUMAN ERROR. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. A BIASED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT EXPERIENCED A TRANSFUSION REACTION AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407201 0.8% SURG 3X10ML REAGENT RED BLOOD CELLS QHT ORTHO-CLINICAL DIAGNOSTICS, INC. 6902316 VSS420 10758750007660

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death