BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE TCS 0.8%

    MDR report key: 22977506 · Received September 5, 2025

    Report

    Report Number
    3002806769-2025-00009
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MEDION GRIFOLS DIAGNOSTICS AG
    Product Code
    QHT
    UDI-DI
    07640137340384
    PMA / PMN Number
    BL103898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    I. DOCUMENTARY INVESTIGATION THE MANUFACTURING DOCUMENTATION OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, WAS REVIEWED AND NO DEVIATIONS WERE FOUND THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. ALL INTERNAL TESTS PERFORMED DURING THE MANUFACTURING PROCESS WERE WITHIN INTERNAL SPECIFICATIONS. ALL FYA+ CELLS FROM THE SCREENING PANEL WERE INTERPRETED AS 3+ WHEN TESTED AGAINST ANTI- FYA MONO-TYPE, REF. 213208, LOT 656325011A, EXP. 2026-12-31. CELL III OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, WAS PREPARED WITH DONOR (B)(6). THE ENTRY TYPING OF THIS DONOR WAS REVIEWED AND NO DEVIATIONS WERE FOUND. DONOR (B)(6) WAS INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF ANTI-FYA REAGENTS AND POSITIVE REACTIONS WERE OBTAINED. THE DONOR (B)(6) IS A NEW DONOR; ITS FIRST AND ONLY USE HAS BEEN IN THE MANUFACTURING OF THE CLAIMED CELL III OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16. BESIDES THE CURRENT REPORTED EVENT, NO OTHER COMPLAINT HAS BEEN REGISTERED TO DATE BY (B)(6) FOR SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, NOR INVOLVING THE DONOR (B)(6). INTERNAL STABILITY RECORDS OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, WERE REVIEWED AND THE EXPECTED RESULTS WERE OBTAINED AT ALL TIME POINTS. ALL FYA+ CELLS FROM THE SCREENING PANEL GAVE STRONG REACTIONS (3+) WHEN TESTED AGAINST ANTI-FYA MONO-TYPE, REF. 213208, LOT 656324011A, EXP. 2026-01-31. II. INVESTIGATIVE TESTING TITRATION OF A SINGLE SOURCE POLYCLONAL ANTI-FYA, WITH SELECTED FYA+ RRBCS, INCLUDING THE CLAIMED CELL III AS WELL AS THE OTHER FYA+ CELLS OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, AND DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025015, EXP. 2025-08-30, WAS DONE IN MANUAL METHOD IN OUR QUALITY CONTROL LABORATORY AT (B)(6). THE THREE HETEROZYGOUS FYA+ RRBCS TESTED, INCLUDING CLAIMED CELL III, GAVE A TITER OF 1:64. THE FIVE HOMOZYGOUS FYA+ RRBCS SHOWED A TITER BETWEEN 1:64 AND 1:128. THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY AND DO NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL FYA ANTIGEN EXPRESSION OF THE CLAIMED CELL III OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16. BASED ON ALL THE ELEMENTS, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS WITH CELL III (DONOR (B)(6) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, IS SAMPLE RELATED, POINTING TO A LOW-TITER ANTI-FYA IN THE PATIENT PLASMA WITH FYA SPECIFICITY THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS LOW ANTI-FYA LEVEL IN THE PATIENT PLASMA SAMPLE, IN COMBINATION WITH NATURALLY OCCURRING VARIATIONS IN THE ANTIGEN DENSITY OF RED BLOOD CELLS MAY BE THE CAUSE OF THE UNEXPECTED RESULTS OBSERVED BY THE CUSTOMER. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCT SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS ON ERYTRA EFLEXIS FOR ONE PATIENT SAMPLE, OBTAINED WITH CELL III (FYA+B-, DONOR (B)(6) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16 UDI: (B)(4). ACCORDING TO THE INFORMATION IN THE WORK ORDER, THE SAMPLE "(B)(6)" WAS COLLECTED ON (B)(6) 2025 AND ORIGINATES FROM A 76-YEAR-OLD MALE PATIENT. THE PATIENT HAS A HISTORY OF ANTI-K ANTIBODY AND NO RECENT TRANSFUSION HISTORY (LAST TRANSFUSION WAS ON (B)(6) 2019). ON (B)(6) 2025, THE CUSTOMER PERFORMED ANTIBODY SCREENING OF SAMPLE "(B)(6)" ON ERYTRA EFLEXIS 2266 USING THE CLAIMED SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, WITH DG GEL 8 ANTI-IGG CARD, REF. 210394, LOT 25007.1, EXP. 2025-12-31. WHILE CELL I (K+, K+, FYA+B-) REACTED POSITIVE (3+), CELL II (K-, K+, FYA-B+) AND THE CLAIMED CELL III (K-, K+, FYA+B+) WERE NEGATIVE. THE CUSTOMER THEN PERFORMED ANTIBODY IDENTIFICATION OF THE SAMPLE ON THE SAME INSTRUMENT USING DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025015, EXP. 2025-08-30. CELL 2 (K+, K-, FYA+B+), CELL 5 (K-, K+, FYA+B-), AND CELL 8 (K+, K+, FYA-B+) AS WELL AS THE AUTOCONTROL REACTED POSITIVE (CELL 2: 3+, CELL 5: 2+, CELL 8: 3+, AC: 1+). ONLY CELL 2 AND CELL 8 ARE K+. ALL OTHER CELLS INCLUDING CELL 1 (K-, K+, FYA+B-, DONOR M6719AM) AND CELL 7 (K-, K+, FYA+B-, DONOR M7579CC) WERE NEGATIVE. ONLY CELL 1, CELL 5, AND CELL 7 ARE FYA HOMOZYGOUS, AND ONLY CELL 2 IS FYA HETEROZYGOUS. THE CUSTOMER STATED THAT THEIR REFERENCE LABORATORY DETECTED BOTH ANTI-K, ANTI-FYA USING TUBE TECHNIQUE. ON (B)(6) 2025, THE CUSTOMER PERFORMED ANTIBODY IDENTIFICATION USING TUBE TECHNIQUE WITH SELECTED CELLS OF A PANEL FROM AN ALTERNATIVE MANUFACTURER WITH LISS AND BY INCUBATING AT 37 °C FOR 15 MINS. THE CUSTOMER STATED THAT ALL CELLS USED IN THIS TEST WERE WRA-. CUSTOMER STATED FOR THIS TEST THAT THEY DID NOT DETECT THE ANTI-FYA ON ALL THE FYA POSITIVE CELLS AND A COUPLE OF THE REACTIONS WERE MICROSCOPIC POSITIVE. CELL 1 (K+, K+, FYA+B+) REACTED POSITIVE (3+). CELL 8 (K-, K+, FYA+B-) AND CELL 10 (K-, K+, FYA+B-) REACTED POSITIVE (+/-). CELL 5 (K-, K+, FYA+B-) AND CELL 6 (K-, K+, FYA+B+) REACTED NEGATIVE. ON (B)(6) 2025, THE CUSTOMER REPEATED THE ANTIBODY IDENTIFICATION ON THE SAME ERYTRA EFLEXIS INSTRUMENT WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025015, EXP. 2025-08-30, AND DG GEL 8 ANTI-IGG CARD, REF. 210394, LOT 25007.1, EXP. 2025-12-31. THE SAME RESULTS AS DURING THE INITIAL TESTING WERE OBTAINED. CELL 2, CELL 5, AND CELL 8 AS WELL AS THE AUTOCONTROL REACTED POSITIVE (CELL 2: 3+, CELL 5: 2+, CELL 8: 3+, AC: 1+). ACCORDING TO L2 INVESTIGATION, A REVIEW OF THE LOGS SHOWED NO ERRORS OR WARNINGS AT THE TIME THAT THE SAMPLE WAS RUN. A REVIEW OF THE PRE-PROCESSING INTEGRITY CHECK IMAGES SHOWED GEL CARD INTEGRITY THAT WERE ACCEPTABLE WITH NO BUFFER SPLASHING OR DISPLACED GEL. THE POST-PROCESSING FINAL READ IMAGES SHOWED AGGLUTINATION PATTERNS THAT ARE VISUALLY CONSISTENT WITH THE ALGORITHM CALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321080 SEARCH-CYTE TCS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY DETECTION QHT MEDION GRIFOLS DIAGNOSTICS AG N/A 644725021 07640137340384

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male