PROCLEIX BABESIA ASSAY

Description of Event or Problem

GRIFOLS BECAME AWARE OF A CASE OF LIKELY TRANSFUSION TRANSMITTED BABESIOSIS FROM AN ARTICLE: HOPKINS C, GRESENS C, BAKHTARY S, VASSALLO R. POSSIBLE NAT-NEGATIVE. TRANSFUSION-TRANSMITTED BABESIA MICROTI. TRANSFUSION. 2025;65(11):2199-202. THE ARTICLE DESCRIBED A (B)(6) DONOR REINSTATED ALMOST 3.5 YEARS AFTER A BABESIA NAT-POSITIVE DONATION WHOSE FIRST POST-REINSTATEMENT DONATION TESTED NAT-NEGATIVE. THREE MONTHS LATER, A SUBSEQUENT DONATION TESTED NAT POSITIVE FOR BABESIA MICROTI. NOTIFICATION OF THE HOSPITAL THAT TRANSFUSED THE NAT-NEGATIVE RED BLOOD CELL UNIT REVEALED A LIKELY B. MICROTI TRANSMISSION. THE DONATION OCCURRED IN (B)(6) 2023 AND WAS TRANSFUSED IN (B)(6) 2023. THE DONOR RETURNED FOR ANOTHER COLLECTION IN (B)(6) 2023, AND THAT RESULT WAS REACTIVE IDT AND IN A POOL. THE RECIPIENT ALSO TESTED REACTIVE FOR BABESIA. NEITHER THE DONOR NOR THE RECIPIENT EXHIBITED SYMPTOMS OF INFECTION. THE RECIPIENT WAS TREATED WITH ANTIBIOTICS AS A PREVENTIVE MEASURE AND THE DONOR REMAINED UNTREATED THROUGH (B)(6) 2025 WHEN THE DONOR REQUESTED REINSTATEMENT. CUSTOMER TESTING/ TIMELINE: (B)(6) 2018 DONOR X TESTS NONREACTIVE IN NAT (B)(6) 2018 DONOR X TESTS REACTIVE IN NAT (POOL-16, IDT) +2 WEEKS IGG REACTIVE, NR IN ALTERNATE ASSAY (B)(6) 2019 LAST NAT REACTIVE RESULT FROM 10-MONTH FOLLOW UP TESTING (B)(6) 2023 DONOR X REQUESTS RE-ENTRY, TESTS NONREACTIVE IN NAT (POOL-16) (B)(6) 2023 RECIPIENT Y IS TRANSFUSED WITH LEUKOREDUCED RBC UNIT FROM DONOR X (B)(6) 2023 DONOR X TESTS REACTIVE IN NAT (POOL AND IDT); IS ASYMPTOMATIC, RECEIVES, NO TREATMENT, LOOKBACK TRIGGERED +76 DAYS* RECIPIENT Y TESTS NEGATIVE IN THICK AND THIN SMEARS BUT POSITIVE FOR B.MICROTI IN A TICK-BORNE DISEASE PANEL (PCR); IS ASYMPTOMATIC, RECEIVES ANTIBIOTICS *AFTER TRANSFUSION. NO REMAINING SAMPLE IS AVAILABLE FOR INVESTIGATION AND THE REAGENT MASTER LOT (ML) WAS NOT AVAILABLE. A PREVIOUS EVENTS SEARCH FOR POTENTIAL FALSE NEGATIVE BABESIA RESULTS IN THE TWO YEARS PRIOR TO THE DONATION IN QUESTION YIELDED NO OTHER OCCURRENCES. THE RISK OF A POTENTIAL FALSE NEGATIVE RESULT WAS ASSESSED ACCORDING TO GRIFOLS PRODUCT SAFETY RISK MANAGEMENT PROCEDURE. NO NEW RISKS WERE IDENTIFIED. THE TRANSMISSION OF INFECTION FROM DONOR TO RECIPIENT WAS LIKELY BUT NOT CONFIRMED. NEITHER THE DONOR, NOR THE RECIPIENT SUFFERED ADVERSE SYMPTOMS FROM INFECTION. THE IMPACT TO THE CUSTOMER WAS ADDITIONAL TESTING. THE IMPACT TO THE ASSAY COULD NOT BE DETERMINED WITHOUT ADDITIONAL TESTING TO IDENTIFY THE ROOT CAUSE OF THE POTENTIALLY FALSE NEGATIVE RESULT. A FALSE NEGATIVE BLOOD SCREENING RESULT HAS A SEVERITY OF CRITICAL AS IT MAY LEAD TO INFECTIONS IN MULTIPLE RECIPIENTS OF AN INFECTED DONATION. THE PROBABILITY OF A FALSE NEGATIVE RESULT IN THE PROCLEIX BABESIA ASSAY IS IMPROBABLE BASED ON THE PREVIOUS EVENTS SEARCH. FOLLOWING ISO 14971, GRIFOLS RISK ASSESSMENT IS BASED ON SEVERITY OF 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 THE PROBABILITY RATING OF IMPROBABLE, THE OVERALL RISK POSED BY A FALSE NEGATIVE RESULT IN THE BABESIA ASSAY IS ACCEPTABLE. GRIFOLS REVIEWED THE DEVICE HISTORY RECORD FOR THE MLS IN USE AT THE TIME OF TESTING: (B)(6) (EXPIRATION DATE 15APR2023) AND (B)(6) (EXPIRATION DATE 15JUL2024). NO ISSUES WERE IDENTIFIED DURING MANUFACTURE OR QC RELEASE THAT COULD HAVE CONTRIBUTED TO FALSE NEGATIVE RESULTS WERE IDENTIFIED FOR EITHER ML. ROOT CAUSE OF THE POTENTIAL FALSE NEGATIVE RESULT COULD NOT BE DETERMINED WITHOUT ADDITIONAL SAMPLE FOR TESTING. QUANTITATION ON THE DONOR SAMPLE AND OR POOL AT THE TIME OF DONATION COULD CONFIRM IF THE TITER WAS ABOVE OR BELOW THE BABESIA ASSAY LIMIT OF DETECTION. SEQUENCING OF THE DONOR AND RECIPIENT COULD HAVE CONFIRMED IF THE RECIPIENT'S INFECTION WAS ACQUIRED FROM TRANSFUSION TRANSMISSION . NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME AS THE ROOT CAUSE OF THE POTENTIAL FALSE NEGATIVE RESULT CANNOT BE CONFIRMED. THE REVIEW OF PREVIOUS EVENTS AND REVIEW OF THE DEVICE HISTORY INDICATE THE ASSAY IS WORKING AS DESIGNED. NO FURTHER INFORMATION IS EXPECTED; THIS IS THE FINAL REPORT.

Additional Manufacturer Narrative

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