BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE TCS 0.8%

    MDR report key: 21991364 · Received May 9, 2025

    Report

    Report Number
    3002806769-2025-00004
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 9, 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 644725009, EXP. 2025-04-26, 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 1 AND CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, GAVE ALL STRONG 4+ REACTIONS WHEN TESTED WITH ANTI-D IGM MONO-TYPE, REF. 213524, LOT 650723001A, EXP. 2027-01-11. ADDITIONALLY, BOTH CELLS WERE ALSO TESTED WITH A DILUTED ANTI-D (LOT 1635, EXP. 2025-03-24) ON DG GEL 8 ANTI-IGG CARD, LOT 24019.01, EXP. 2025-04-30, AND REACTED POSITIVE WITH 2+ REACTIONS. A COMPLAINT DATABASE SEARCH WAS PERFORMED, CONCLUDING THAT NO OTHER SIMILAR COMPLAINT FOR SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, HAS BEEN REGISTERED TO DATE BY MEDION GRIFOLS DIAGNOSTICS AG. CELL 1 AND CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, WERE PREPARED WITH DONORS (B)(6), RESPECTIVELY. THE ENTRY TYPING OF THE TWO DONORS WAS REVIEWED AND NO DEVIATIONS WERE FOUND. THE DONORS (B)(6) WERE INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-D AND STRONG POSITIVE REACTIONS WERE OBTAINED. ADDITIONALLY, THE DONORS WERE TESTED WITH A DILUTED ANTI-D AND THEY GAVE POSITIVE REACTIONS, RESPECTIVELY. THEY WERE ALSO TESTED WITH SEROWEAK-CONTROL, REF. 213399, LOTS 638123011, EXP. 2023-07-08, AND 638123017, EXP. 2023-09-30, AND BOTH GAVE POSITIVE RESULTS. TWO BLOOD UNITS OF DONOR (B)(6) HAVE BEEN USED IN THE MANUFACTURING OF TWO FINISHED PRODUCTS AMONG TWO MANUFACTURING CAMPAIGNS. BESIDES THE CURRENT REPORTED EVENT FOR SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, FOR THE PRODUCTS MANUFACTURED WITH THIS DONOR, THERE HAS BEEN NO OTHER COMPLAINT REGARDING A MISSED ANTI-D INVOLVING DONOR (B)(6) REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG. TWO BLOOD UNITS OF DONOR M7509LS HAVE BEEN USED IN THE MANUFACTURING OF TWO FINISHED PRODUCTS AMONG TWO MANUFACTURING CAMPAIGNS. BESIDES THE CURRENT REPORTED EVENT FOR SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, FOR THE PRODUCTS MANUFACTURED WITH THIS DONOR, THERE HAS BEEN NO OTHER COMPLAINT REGARDING A MISSED ANTI-D INVOLVING DONOR M7509LS REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG. INTERNAL STABILITY RECORDS OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, WERE REVIEWED AND THE EXPECTED RESULTS WERE OBTAINED AT ALL TIME POINTS. II. INVESTIGATIVE TESTING: INVESTIGATIVE TESTING OF A DILUTED ANTI-D WITH DIFFERENT RRBCS, INCLUDING THE CLAIMED SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, AS WELL AS GRIFOLS RRBCS (ONE ANTIBODY SCREENING PANEL AND ONE IDENTIFICATION PANEL) WITH SAME EXPIRATION DATE, WAS PERFORMED ON ERYTRA INSTRUMENT IN OUR QUALITY CONTROL LABORATORY AT MEDION GRIFOLS DIAGNOSTICS AG. NOTE: AN ANTIBODY-FREE DONOR SAMPLE WAS TESTED IN PARALLEL AS NEGATIVE CONTROL AND PRODUCED NEGATIVE REACTIONS FOR ALL TESTED CELLS. ALL TEN D+ RRBCS TESTED AMONG THE THREE PANELS WITH SAME EXPIRATION DATE, INCLUDING THE CLAIMED CELL 1 AND CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, SHOWED COMPARABLE REACTIONS, WHICH RANGED BETWEEN 2+ AND 3+. THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY AND DO NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL D ANTIGEN EXPRESSION OF THE CLAIMED CELL 1 AND CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26. THUS, THE INVESTIGATIVE TESTING IS SUPPORTING THE HYPOTHESIS OF THE PRESENCE OF A LOW-TITER ANTI-D 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 1 (DONOR (B)(6)) AND CELL 2 (DONOR (B)(6)) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, IS SAMPLE RELATED, POINTING TO A LOW-TITER ANTI-D IN THE PATIENT PLASMA WITH D SPECIFICITY THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS LOW ANTI-D 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. 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 644725009, EXP. 2025-04-26. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS FOR ONE PATIENT SAMPLE WITH HISTORY OF ANTI-D, OBTAINED WITH CELL 1 (DONOR (B)(6)) AND CELL 2 (DONOR (B)(6)) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26 (UDI: (B)(4). THE SAMPLE "(B)(6)" WAS COLLECTED ON (B)(6) 2025 AND ORIGINATES FROM A 43-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH SICKLE CELL ANEMIA AND WHO HAD TRANSFUSION HISTORY (NO FURTHER DETAILS PROVIDED). ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT HAS A HISTORY OF ANTI-D, ANTI-C, ANTI-E, ANTI-FYA, ANTI-JKB, ANTI-JSA, ANTI-K AND ANTI-S. THE LAST PANEL PERFORMED ON (B)(6) 2025 WITH REAGENTS FROM ALTERNATIVE MANUFACTURER REVEALED THE PRESENCE OF ANTI-D. SAMPLE WAS IDENTIFIED AS BEING ICTERIC. ALL TESTING WAS PERFORMED ON (B)(6) 2025. NO NEW ANTIBODY WAS IDENTIFIED USING THIS SAMPLE. BASED ON THE DOCUMENTATION PROVIDED: SAMPLE "(B)(6)" WAS TESTED FOR FORWARD ABO/RH GROUPING AT 15H02 ON ERYTRA EFLEXIS EFL2247 (SN (B)(6), SOFTWARE VERSION 3.2.0, UNKNOWN REAGENT PACK VERSION) USING DG GEL 8 ABD CARD, LOT 25001.1, EXP. 2025-12-31. THE A MICROTUBE WAS INTERPRETED AS A MIXED FIELD (MF) BUT MODIFIED TO 4+ BY THE OPERATOR, THE B MICROTUBE WAS NEGATIVE AND THE D MICROTUBE WAS INTERPRETED AS 2+, RESULTING IN AN A+ RESULT FOR THE FORWARD GROUPING AND RH POSITIVE. THE CTL MICROTUBE WAS NEGATIVE. THE SAMPLE WAS TESTED IN PARALLEL FOR REVERSE GROUPING WITH REVERSE-CYTE A1, B 0.8%, REF. 213660, LOT 641425011, EXP. 2025-04-26, ON DG GEL 8 NEUTRAL CARD, LOT 25001.1, EXP. 2025-11-30, AND A1 CELL WAS NEGATIVE WHILE THE B CELL REACTED POSITIVE (4+) WHICH RESULTED IN AN A RESULT FOR THE REVERSE GROUPING, THEREFORE CONSISTENT WITH THE FORWARD GROUPING RESULT. THE SAMPLE WAS TESTED FOR ANTIBODY SCREENING ON EFL2247 AT 15H10 USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, ON DG GEL 8 ANTI-IGG CARD, LOT 25001.1, EXP. 2025-12-31, AND ALL THREE SCREENING CELLS WERE INTERPRETED AS NEGATIVE. VISUAL REVIEW BY L2 SHOWED A VERY FAINT RED HAZE ABOVE THE NEGATIVE CELL BUTTON FOR CELL 1. ALL THREE MICROTUBES HAVE OTHERWISE CLEAN NEGATIVE PELLETS AND ARE CORRECTLY ASSIGNED AS NEGATIVE. ANTIBODY SCREENING WITH REAGENTS FROM ALTERNATIVE MANUFACTURER WAS PERFORMED AT 15H15 AND BOTH D+ CELL 1 AND CELL 2 REACTED POSITIVE (1+ AND 2+, RESPECTIVELY). THE SAMPLE WAS THEN TESTED FOR ANTIBODY SCREENING ON ERYTRA EFLEXIS EFL2246 (SN (B)(6), SOFTWARE VERSION 3.2.0, UNKNOWN REAGENT PACK VERSION) AT 15H46 USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725009, EXP. 2025-04-26, ON DG GEL 8 ANTI-IGG CARD, LOT 25001.1, EXP. 2025-12-31 AND ALL THREE SCREENING CELLS WERE INTERPRETED AS NEGATIVE. VISUAL REVIEW BY L2 IS CONSISTENT WITH TESTING PERFORMED ON EFL2247 AT 15H10 DESCRIBED ABOVE. AT 16H28, A RETEST ON THE SAME INSTRUMENT USING INVESTIGATIVE METHOD TEST PROFILE WITH 50 L PLASMA/SERUM WAS PERFORMED WITH THE SAME REAGENTS, AND THE RESULTS REMAINED NEGATIVE. VISUAL REVIEW BY L2 IS CONSISTENT WITH THE STANDARD ANTIBODY SCREENING RESULTS. PELLETS ARE CORRECTLY ASSIGNED AS NEGATIVE. THE SAMPLE WAS RETESTED ON EFL2247 AT 16H37 WITH THE SAME REAGENTS USING THE SAME INVESTIGATIVE TEST PROFILE WITH 50 L PLASMA/SERUM, AND THE SAME NEGATIVE RESULTS WERE OBTAINED. VISUAL REVIEW SHOWS SOME VERY SLIGHT IRREGULARITY IN CELL 1 AND CELL 2 PELLETS. MICROTUBES ARE CORRECTLY ASSIGNED AS NEGATIVE. THE PLASMA WAS ICTERIC ACCORDING TO ALL THE PICTURES FROM THE TRACEABILITY REPORTS. ACCORDING TO L2 INVESTIGATION THE INSTRUMENT LOG REVIEW SHOWED NO ERRORS DURING THE TIME OF TESTING. DAILY QUALITY CONTROL TESTING FOR ANTIBODY SCREENING WAS COMPLETED WITHOUT ERROR AND WITH EXPECTED RESULTS. REVIEW OF THE STANDARD ANTIBODY SCREENING QC TESTING SHOWED SOME UNUSUAL LINES OF CELLS AT THE TOP OF THE GEL FOR THE 2+ AND 3+ REACTIONS ON THE QC01 SAMPLE AND THE 3+ REACTION FOR THE QC04 SAMPLE. ALL AGGLUTINATION PATTERNS ARE VISUALLY CONSISTENT WITH THE INSTRUMENT ALGORITHM REACTION GRADE ASSIGNMENTS. NO OBVIOUS INSTRUMENT ISSUES ARE NOTED, CARD INTEGRITY IS ACCEPTABLE, AND THE REAGENTS PERFORMED AS EXPECTED FOR OTHER SAMPLES TESTED BEFORE AND AFTER. THE PATIENT HAS SICKLE CELL ANEMIA, WHICH SUGGESTS THE PATIENT IS HYPER TRANSFUSED. ACCORDINGLY, THE PATIENT HAS A HISTORY OF MULTIPLE ALLO-ANTIBODIES. THE MOST RECENT TESTING WITH REAGENTS FROM ALTERNATIVE MANUFACTURER SHOWS A REACTIVITY PATTERN THAT REFLECTS ANTI-D ONLY. THE OTHER HISTORIC ANTIBODIES ARE NOT CURRENTLY DEMONSTRATING, SUGGESTING PATIENT CARE HAS BEEN DONE USING PROPER BLOOD BANKING AND TRANSFUSION SERVICE PRACTICES OF PROVIDING ANTIGEN NEGATIVE, CROSSMATCH COMPATIBLE UNITS. THE ANTI-D ACTIVITY WITH 1+/2+ REACTION STRENGTH WITH ALTERNATIVE MANUFACTURER REAGENTS SUGGESTS THE PRESENCE OF A LOW TITER ANTI-D. THE INVESTIGATIVE TESTING PERFORMED ON EFL2247 ALSO HINTS AT THIS, AS BOTH D+ SCREENING CELLS SHOWED A SLIGHTLY IRREGULAR CELL BUTTON WHEN USING HIGHER PLASMA VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794736 SEARCH-CYTE TCS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY DETECTION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 644725009 07640137340384

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female