BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEIX ULTRIO ELITE ASSAY

    MDR report key: 18822857 · Received March 1, 2024

    Report

    Report Number
    2032600-2024-00001
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    January 21, 2024
    Report Date
    May 23, 2024
    Manufacturer
    GRIFOLS DIAGNOSTIC SOLUTIONS INC.
    Product Code
    QHO
    UDI-DI
    00859882007672
    PMA / PMN Number
    BL125652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER (B)(6) UNIVERSITY (SAUDI ARABIA) REPORTED ON 05FEB2024 INITIAL ULTRIO ELITE NONREACTIVE RESULTS FOR DONOR SAMPLE USING LN 706570. SEROLOGY RESULTS WERE REACTIVE FOR HBSAG AND ANTI-HBC. DISCRIMINATORY DHBV TESTS WERE REACTIVE. REPEAT UE TEST USING SAME TUBE WAS REACTIVE. DONOR ADMITTED TO HAVING HBV. DONATION WAS NOT USED FOR TRANSFUSION. NO REMAINING SAMPLE WAS AVAILABLE FOR INVESTIGATION. SUMMARY OF TESTING: (B)(6) 2024. SAMPLE (B)(6). RESULTS: ULTRIO ELITE NONREACTIVE S/CO 0.12. SAMPLE (B)(6). (SEROLOGY TUBE FROM THE SAME DONOR) RESULTS: HBSAG REACTIVE (3 REPLICATES). ANTI-HBC REACTIVE (3 REPLICATES). (B)(6) 2024. SAMPLE (B)(6). (SEROLOGY TUBE FROM THE SAME DONOR) RESULTS: ULTRIO ELITE REACTIVE S/CO 12.34. DHBV REACTIVE S/CO 23.49. IN ADDITION, THE CUSTOMER INDICATED THAT PCR TESTING TOOK PLACE IN (B)(6) 2023. IN THIS PARTICULAR CASE, NAT AND SEROLOGY WERE CARRIED OUT ON (B)(6) 2024. SINCE THE CONVENTIONAL PRACTICE INVOLVES CONDUCTING PCR AS A CONFIRMATORY TEST FOLLOWING NAT AND SEROLOGY, IT IS HIGHLY PROBABLE THAT THE PCR TESTED A SAMPLE OBTAINED FROM A PRIOR DRAW. CONSEQUENTLY, THE PCR OUTCOME FROM DECEMBER 2023 WILL NOT BE CONSIDERED IN ASSESSING THE PERFORMANCE OF THE ULTRIO ELITE ASSAY. RISK ANALYSIS: SEVERITY: CRITICAL. A SINGLE BLOOD SCREENING FALSE NEGATIVE (FN) RESULT CAN CAUSE MULTIPLE INFECTIONS. THE SEVERITY OF A BLOOD SCREENING FALSE NEGATIVE IS CRITICAL. PROBABILITY: REMOTE. THE PROBABILITY OF A FALSE NEGATIVE RESULT IS REMOTE. FALSE NEGATIVE RESULTS DO OCCUR BUT ARE RARE. OVERALL RISK: ACCEPTABLE. GDSS-RSK-000044, PANTHER ASSAY SPECIFIC RISK ANALYSIS FOR BLOODBANK ASSAYS (RSK-00854) AND PRODUCT SAFETY RISK MANAGEMENT PROCEDURE, 04-03-12-SOP WERE REVIEWED TO ASSESS RISK. NEW RISK TO PATIENT SAFETY WAS NOT IDENTIFIED. THERE WERE NO RELATED NONCONFORMANCES NOTED IN THE MANUFACTURING RECORD OR AS PART OF A SEARCH OF THE NONCONFORMANCE RECORDS FOR THIS LOT NUMBER. PRODUCT IMPACT: NO IMPACT TO PRODUCT WAS IDENTIFIED. THE ROOT CAUSE OF THE INITIAL NONREACTIVE WAS NOT DETERMINED DUE TO LACK OF SAMPLE. REVIEW OF THE QC RELEASE DATA AND A PREVIOUS EVENTS SEARCH IN THE GRIFOLS COMPLAINT SYSTEM INDICATE THAT THE ASSAY IS WORKING AS DESIGNED. CUSTOMER IMPACT: THE IMPACT TO THE CUSTOMER WAS QUESTIONING THE ULTRIO ELITE RESULTS. DONATION WAS NOT USED FOR TRANSFUSION. GRIFOLS RISK ASSESSMENT IS BASED ON SEVERITY OF A HARM OR IMPACT TO HUMAN HEALTH AND THE PROBABILITY OF OCCURRENCE OF HARM OR IMPACT TO HUMAN HEALTH. BASED ON THE SEVERITY RATING OF ·CRITICAL· AND PROBABILITY RATING OF ·REMOTE·, THE OVERALL RISK POSED BY A FALSE NEGATIVE ULTRIO ELITE RESULT IS DETERMINED TO BE ACCEPTABLE. INVESTIGATIONAL TESTING IS IN PROGRESS. FOLLOW-UP INFORMATION FOR THIS REPORT WILL BE PROVIDED WHEN AVAILABLE.

    Description of Event or Problem · 0

    CUSTOMER KING ABDULAZIZ UNIVERSITY (SAUDI ARABIA) REPORTED ON 05FEB2024 INITIAL ULTRIO ELITE NONREACTIVE RESULTS FOR DONOR SAMPLE USING LN 706570. SEROLOGY RESULTS WERE REACTIVE FOR HBSAG AND ANTI-HBC. DISCRIMINATORY DHBV TESTS WERE REACTIVE. REPEAT UE TEST USING SAME TUBE WAS REACTIVE. DONOR ADMITTED TO HAVING HBV. DONATION WAS NOT USED FOR TRANSFUSION. NO REMAINING SAMPLE WAS AVAILABLE FOR INVESTIGATION. SUMMARY OF TESTING: (B)(6) 2024. SAMPLE (B)(6) RESULTS: ULTRIO ELITE NONREACTIVE S/CO 0.12. SAMPLE (B)(6) (SEROLOGY TUBE FROM THE SAME DONOR) RESULTS: HBSAG REACTIVE (3 REPLICATES) ANTI-HBC REACTIVE (3 REPLICATES). 22JAN2024. SAMPLE 1109634 (SEROLOGY TUBE FROM THE SAME DONOR) RESULTS: ULTRIO ELITE REACTIVE S/CO 12.34. DHBV REACTIVE S/CO 23.49. IN ADDITION, THE CUSTOMER INDICATED THAT PCR TESTING TOOK PLACE IN (B)(6) 2023. IN THIS PARTICULAR CASE, NAT AND SEROLOGY WERE CARRIED OUT ON (B)(6) 2024. SINCE THE CONVENTIONAL PRACTICE INVOLVES CONDUCTING PCR AS A CONFIRMATORY TEST FOLLOWING NAT AND SEROLOGY, IT IS HIGHLY PROBABLE THAT THE PCR TESTED A SAMPLE OBTAINED FROM A PRIOR DRAW. CONSEQUENTLY, THE PCR OUTCOME FROM (B)(6) 2023 WILL NOT BE CONSIDERED IN ASSESSING THE PERFORMANCE OF THE ULTRIO ELITE ASSAY. RISK ANALYSIS SEVERITY: CRITICAL. A SINGLE BLOOD SCREENING FALSE NEGATIVE (FN) RESULT CAN CAUSE MULTIPLE INFECTIONS. THE SEVERITY OF A BLOOD SCREENING FALSE NEGATIVE IS CRITICAL. PROBABILITY: REMOTE. THE PROBABILITY OF A FALSE NEGATIVE RESULT IS REMOTE. FALSE NEGATIVE RESULTS DO OCCUR BUT ARE RARE. OVERALL RISK: ACCEPTABLE. GDSS-RSK-000044, PANTHER ASSAY SPECIFIC RISK ANALYSIS FOR BLOODBANK ASSAYS (RSK-00854) AND PRODUCT SAFETY RISK MANAGEMENT PROCEDURE, 04-03-12-SOP WERE REVIEWED TO ASSESS RISK. NEW RISK TO PATIENT SAFETY WAS NOT IDENTIFIED. THERE WERE NO RELATED NONCONFORMANCES NOTED IN THE MANUFACTURING RECORD OR AS PART OF A SEARCH OF THE NONCONFORMANCE RECORDS FOR THIS LOT NUMBER. PRODUCT IMPACT NO IMPACT TO PRODUCT WAS IDENTIFIED. THE ROOT CAUSE OF THE INITIAL NONREACTIVE WAS NOT DETERMINED DUE TO LACK OF SAMPLE. REVIEW OF THE QC RELEASE DATA AND A PREVIOUS EVENTS SEARCH IN THE GRIFOLS COMPLAINT SYSTEM INDICATE THAT THE ASSAY IS WORKING AS DESIGNED. CUSTOMER IMPACT THE IMPACT TO THE CUSTOMER WAS QUESTIONING THE ULTRIO ELITE RESULTS. DONATION WAS NOT USED FOR TRANSFUSION. GRIFOLS RISK ASSESSMENT IS BASED ON SEVERITY OF A HARM OR IMPACT TO HUMAN HEALTH AND THE PROBABILITY OF OCCURRENCE OF HARM OR IMPACT TO HUMAN HEALTH. BASED ON THE SEVERITY RATING OF ·CRITICAL· AND PROBABILITY RATING OF ·REMOTE·, THE OVERALL RISK POSED BY A FALSE NEGATIVE ULTRIO ELITE RESULT IS DETERMINED TO BE ACCEPTABLE. INVESTIGATIONAL TESTING IS IN PROGRESS. FOLLOW-UP INFORMATION FOR THIS REPORT WILL BE PROVIDED WHEN AVAILABLE. 23MAY2024: NO FURTHER INFO IS AVAILABLE. THIS IS THE FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229027 PROCLEIX ULTRIO ELITE ASSAY HIV-1/HIV-2/HCV/HBV DEVICE QHO GRIFOLS DIAGNOSTIC SOLUTIONS INC. 706570 00859882007672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other