BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE TCS 0.8%

    MDR report key: 22381979 · Received July 2, 2025

    Report

    Report Number
    3002806769-2025-00005
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 2, 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 644725015, EXP. 2025-06-21, 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. AT RELEASE, THE CLAIMED CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21, GAVE A STRONG 4+ REACTION WHEN TESTED WITH DG GEL 8 RH-PHENO, REF. 210228, LOT 23001.01, EXP. 2025-04-30. CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21, WAS PREPARED WITH DONOR (B)(6). THE ENTRY TYPING OF THE DONOR WAS REVIEWED AND NO DEVIATIONS WERE FOUND. DONORS (B)(6) WAS INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-E AND STRONG POSITIVE REACTIONS WERE OBTAINED. DONOR (B)(6) IS A NEW DONOR; ITS FIRST AND ONLY USE HAS BEEN IN THE MANUFACTURING OF THE CLAIMED CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21. BESIDES THE CURRENT REPORTED EVENT, NO OTHER COMPLAINT HAS BEEN REGISTERED TO DATE BY MEDION GRIFOLS DIAGNOSTICS AG FOR SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21. INTERNAL STABILITY RECORDS OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21, WERE REVIEWED AND THE EXPECTED RESULTS WERE OBTAINED AT ALL TIME POINTS. II. INVESTIGATIVE TESTING: TITRATION OF A SINGLE SOURCE POLYCLONAL ANTI-E, WITH SELECTED HOMOZYGOUS E+ R2R2 RRBCS, INCLUDING THE CLAIMED CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21, AS WELL AS THE CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725017, EXP. 2025-07-05, BUT ALSO TWO RRBCS FROM COMPETITOR WITH EXPIRATION DATE CLOSE TO THE CLAIMED PRODUCT AND THE NEXT TESTED LOT OF GRIFOLS RRBC, WAS DONE IN MANUAL METHOD IN OUR QUALITY CONTROL LABORATORY AT MEDION GRIFOLS DIAGNOSTICS AG. THE FOUR HOMOZYGOUS E+ R2R2 RRBCS TESTED GAVE A TITER OF 1:1024, SHOWING COMPARABLE RESULTS BETWEEN THE CLAIMED CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21, AND THE CELL 2 OF NEXT LOT OF CLAIMED REAGENT, BUT ALSO WITH CELLS FROM COMPETITOR WITH CLOSE EXPIRATION DATES. THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY AND DO NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL E ANTIGEN EXPRESSION OF THE CLAIMED CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21. THUS, THE INVESTIGATIVE TESTING IS SUPPORTING THE HYPOTHESIS OF THE PRESENCE OF A LOW-TITER ANTI-E ANTIBODY IN THE PATIENT PLASMA THAT IS AT THE DETECTION LIMIT OF THE GEL SYSTEM. BASED ON ALL THE ELEMENTS, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS WITH CELL 2 (DONOR (B)(6)) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21, IS SAMPLE RELATED, POINTING TO A LOW-TITER ANTI-E IN THE PATIENT PLASMA WITH E SPECIFICITY THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS LOW ANTI-E 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. IT SHALL BE NOTED THAT WHILE POSITIVE RESULTS (1+ TO 2+) WERE OBTAINED WITH E+ RRBCS FROM ALTERNATIVE REAGENTS, THE TEST WAS PERFORMED IN TUBE METHOD WITH THE USAGE OF PEG ENHANCER, WHICH FURTHER SUPPORTS THE PRESENCE OF A LOW TITER ANTI-E IN THE PATIENT PLASMA, IN COMBINATION TO THE REACTIVITY PATTERN (1+, +/- AND NEGATIVE) FROM ANTIBODY SCREENINGS PERFORMED WITH GRIFOLS RRBCS BETWEEN (B)(6) 2025, AND THE NEGATIVE ANTIBODY IDENTIFICATION RESULTS WITH GRIFOLS RRBCS OBTAINED DURING TESTING FROM (B)(6) 2025. NO SINGLE METHOD IS ABLE TO DETECT ALL IRREGULAR ANTIBODIES. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCT SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS FOR ONE PATIENT SAMPLE (B)(6) WITH HISTORICAL ANTI-E, OBTAINED ON (B)(6) 2025 WITH CELL 2 (E+E-, DONOR (B)(6)) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21. SAMPLE ORIGINATES FROM A 28-YEAR-OLD PATIENT. NO FURTHER INFORMATION WAS PROVIDED ABOUT THE PATIENT NOR TRANSFUSION HISTORY. THE CUSTOMER STATED THAT ANTIBODY SCREENING TESTS FOR THIS PATIENT WERE RECENTLY SHOWING WEAKER REACTIONS IN THE LAST MONTHS AND THAT WHILE ANTIBODY IDENTIFICATION WAS NEGATIVE, THEY OBTAINED 2+ REACTIONS WHEN THEY PERFORMED TESTING IN TUBE METHOD WITH PEG ENHANCER. THE FOLLOWING RESULTS OBTAINED FOR THE PATIENT WERE PROVIDED: - TESTING OF (B)(6) 2025 (SAMPLE (B)(6)): ANTIBODY SCREENING OF THE SAMPLE WAS PERFORMED AT 17H07 ON ERYTRA ERY1050 (SN (B)(6), SOFTWARE VERSION 4.3.2, UNKNOWN REAGENT PACK VERSION) USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724027, EXP. 2025-02-01, ON DG GEL 8 ANTI-IGG CARD, LOT 24025.01, EXP. 2025-05-31, AND CELL 2 (E+E-) WAS INTERPRETED AS DOUBTFUL "?" AND MODIFIED TO 1+ BY THE OPERATOR. CELL 1 AND CELL 3 WERE INTERPRETED AS NEGATIVE. THE TEST WAS REPEATED IN MANUAL WITH SIMILAR RESULTS (CELL 2 INTERPRETED AS 1+). ANTIBODY IDENTIFICATION WAS THEN PERFORMED AT 18H02 USING DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024025, EXP. 2025-01-18, ON THE SAME GEL CARD LOT, AND ALL CELLS AS WELL AS AUTOCONTROL WERE INTERPRETED AS NEGATIVE INCLUDING THE CELL 4 (E+E+), CELL 10 (E+E-) AND CELL 11 (E+E-). ANTIBODY SCREENING IN TUBE METHOD USING PEG ENHANCER WITH REAGENTS FROM ALTERNATIVE MANUFACTURER RESULTED IN POSITIVE 2+ RESULT FOR CELL 2 IN AHG PHASE. ANTIBODY IDENTIFICATION IN TUBE METHOD USING PEG ENHANCER WITH REAGENTS FROM ALTERNATIVE MANUFACTURER RESULTED IN POSITIVE 1+ RESULTS IN AHG PHASE WITH BOTH E+ CELLS (CELL 2 E+E-; CELL 6 E+E+) FROM THE PANEL. - TESTING OF (B)(6) 2025 (SAMPLE (B)(6)): ANTIBODY SCREENING OF THE SAMPLE WAS PERFORMED AT 17H00 ON THE SAME INSTRUMENT AS TESTING OF (B)(6) 2025 USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, ON DG GEL 8 ANTI-IGG CARD, LOT 24039.01, EXP. 2025-08-31, AND THE CELL 2 (E+E-) WAS INTERPRETED AS DOUBTFUL "?" AND MODIFIED TO W+ BY THE OPERATOR. CELL 1 AND CELL 3 WERE INTERPRETED AS NEGATIVE. ANTIBODY IDENTIFICATION WAS THEN PERFORMED AT 17H34 USING DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617025006, EXP. 2025-04-26, ON THE SAME GEL CARD LOT, AND ALL CELLS AS WELL AS THE AUTOCONTROL WERE INTERPRETED AS NEGATIVE INCLUDING THE CELL 4 (E+E+), CELL 9 (E+E-), AND CELL 10 (E+E-). ANTIBODY IDENTIFICATION IN TUBE METHOD USING PEG ENHANCER WITH REAGENTS FROM ALTERNATIVE MANUFACTURER RESULTED IN POSITIVE 2+ AND 1+ REACTIONS IN AHG PHASE WITH BOTH E+ CELL 2 (E+E-) AND CELL 6 (E+E+) FROM THE PANEL, RESPECTIVELY. - TESTING OF (B)(6) 2025 (SAMPLE (B)(6)): ANTIBODY SCREENING OF THE SAMPLE WAS PERFORMED AT 17H37 ON THE SAME INSTRUMENT AS TESTING OF (B)(6) 2025 USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725015, EXP. 2025-06-21, ON DG GEL 8 ANTI-IGG CARD, LOT 25003.01, EXP. 2025-12-31, AND ALL CELLS WERE INTERPRETED AS NEGATIVE, INCLUDING THE CELL 2 (E+E-, DONOR (B)(6)). NO ANTIBODY IDENTIFICATION WAS PERFORMED IN GEL METHOD. ANTIBODY SCREENING IN TUBE METHOD WAS PERFORMED USING PEG ENHANCER WITH REAGENTS FROM ALTERNATIVE MANUFACTURER AND CELL 2 TESTED 2+ POSITIVE. ANTIBODY IDENTIFICATION IN TUBE METHOD WITH REAGENTS FROM ALTERNATIVE MANUFACTURER AND USING PEG AS ENHANCER RESULTED IN AHG PHASE IN POSITIVE 2+ REACTION WITH CELL 2 (E+E-) AND 1+ REACTIONS WITH CELL 6 AND CELL 11 (BOTH E+E+). CELL 1 (E-E+, KPA+, JKB+) OF REAGENT FROM ALTERNATIVE MANUFACTURER WAS ALSO TESTED IN TUBE METHOD WITH PEG ENHANCER AND WAS INTERPRETED AS NEGATIVE, RULING OUT THE PRESENCE OF ANTI-KPA. AS PER L2 INVESTIGATION, VISUAL REVIEW OF THE TRACEABILITY REPORTS SHOWED AGGLUTINATION PATTERNS IN EACH WELL THAT ARE CONSISTENT WITH THE ALGORITHM REACTION GRADE ASSIGNMENTS. INSTRUMENT LOGS SHOWED NO ERRORS RELATED TO THE REPORTED TESTING. DAILY QC PASSED THE DAYS OF TESTING, AND NO WARNING OR INCIDENT ARE NOTED ON THE RESULTS FOR THE SAMPLES IN QUESTION. REVIEW OF THE PRE-PROCESSING INTEGRITY CHECK RAW IMAGE FILES FOR SAMPLE J80405071 SHOWED NO GEL DISPLACEMENT, BUFFER SPLASHING OR INTEGRITY CHECK ISSUES IN THE CARDS USED FOR TESTING AND THE POST-PROCESSING FINAL IMAGE READS SHOWED AGGLUTINATION PATTERNS THAT ARE VISUALLY CONSISTENT WITH THE ALGORITHM CALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483826 SEARCH-CYTE TCS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY DETECTION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 644725015 07640137340384

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Unknown