BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE PLUS 0.8%

    MDR report key: 25212321 · Received May 19, 2026

    Report

    Report Number
    3002806769-2026-00003
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 19, 2026
    Manufacturer
    MEDION GRIFOLS DIAGNOSTICS AG,
    Product Code
    QHT
    UDI-DI
    07640137340377
    PMA / PMN Number
    BL103898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DOCUMENTATION OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09, 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 PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09, GAVE A STRONG 4+ REACTION FOR THE E ANTIGEN WHEN TESTED WITH DG GEL 8 RH-PHENO, REF. 210228, LOT 25001.01, EXP. 2027-06-30. CELL 2 OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09, WAS PREPARED WITH DONOR (B)(6). THE ENTRY TYPING OF THE DONOR WAS REVIEWED AND NO DEVIATIONS WERE FOUND. DONORS M8357AM WAS INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-E AND 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 PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09. BESIDES THE CURRENT COMPLAINT, NO OTHER COMPLAINT INVOLVING THIS DONOR OR CLAIMED PRODUCT HAS BEEN REGISTERED TO DATE BY MEDION GRIFOLS DIAGNOSTICS AG. TITRATION OF A SINGLE SOURCE POLYCLONAL ANTI-E WITH SELECTED E+ RRBCS, INCLUDING THE CLAIMED CELL 2 OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09, AS WELL AS THE E+ IDENTIFICATION PANEL RRBCS THAT DID NOT REACT AT CUSTOMER SITE (I.E. CELL 4 OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617026008, EXP. 2026-05-23, AS WELL AS CELL 4, CELL 10 AND CELL 11 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026007, EXP. 2026-05-09), AND ONE OF THE TWO HOMOZYGOUS E+ RRBCS THAT REACTED POSITIVE (1+) AT CUSTOMER SITE (CELL 10 OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617026008, EXP. 2026-05-23), BUT ALSO A GRIFOLS NON-EXPIRED SCREENING RRBC (SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526008, EXP. 2026-05-23) AS WELL AS TWO E+ RRBCS (ONE HOMOZYGOUS AND ONE HETEROZYGOUS) FROM COMPETITOR WITH EXPIRATION DATE CLOSE TO THE CLAIMED PRODUCT, WAS DONE IN MANUAL METHOD IN OUR QUALITY CONTROL LABORATORY AT MEDION GRIFOLS DIAGNOSTICS AG. THE SIX HOMOZYGOUS E+ RRBCS (ALL R2R2 EXCEPT CELL 11 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026007, EXP. 2026-05-09, WHICH IS RZR2) TESTED GAVE A TITER BETWEEN 1:2048 AND 1:4096 (INCLUDING THE CLAIMED CELL 2 OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09), SHOWING COMPARABLE RESULTS BETWEEN THE CLAIMED CELL, THE E+ IDENTIFICATION PANEL RRBCS THAT DID (1+) AND DID NOT REACT AT CUSTOMER SITE, BUT ALSO THE RRBC FROM COMPETITOR WITH CLOSE EXPIRATION DATE TO THE CLAIMED PRODUCT, AND WITH A NEWER LOT OF SCREENING RRBC THAT IS NON-EXPIRED. THE THREE HETEROZYGOUS E+ RRBCS TESTED GAVE A TITER OF 1:2048, SHOWING COMPARABLE REACTIVITY BETWEEN THE TESTED RRBCS (INCLUDING BOTH IDENTIFICATION RRBCS THAT DID NOT REACT AT CUSTOMER SITE, AS WELL AS THE RRBC FROM COMPETITOR WITH CLOSE EXPIRATION DATE TO THE CLAIMED PRODUCT). THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY AND DOES NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL E ANTIGEN EXPRESSION OF THE CLAIMED CELL 2 OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09. 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. THERE ARE MULTIPLE FACTORS INVOLVED IN THE RESULT OF AN AGGLUTINATION REACTION. THE DIFFERENCES IN REACTIVITY OBSERVED MOST LIKELY ARE EXPLAINED BY THE CHARACTERISTICS OF THE PLASMA SAMPLE INVOLVED, IN COMBINATION WITH RED BLOOD CELLS ZYGOSITY AND THE NATURAL OCCURRENCE OF FLUCTUATIONS IN THE ANTIGEN DENSITY. THE AGE OF THE RED BLOOD CELLS IS AN ADDITIONAL FACTOR TO CONSIDER. AS WITH ALL RED BLOOD CELLS, THE REACTIVITY OF THE PRODUCT MAY DECREASE DURING THE SHELF-LIFE. THE RATE AT WHICH ANTIGEN REACTIVITY IS LOST IS PARTIALLY DEPENDENT UPON INDIVIDUAL DONOR CHARACTERISTICS THAT ARE NEITHER CONTROLLED NOR PREDICTABLE. HOWEVER, THE INTERNAL TITRATION EXPERIMENTS CLEARLY SHOW THAT THERE IS NO E ANTIGEN EXPRESSION PARTICULARITY ON THE CLAIMED CELLS. ADDITIONALLY, IT SHALL BE NOTED THAT NO ADDITIONAL TESTING USING ENHANCERS WAS CARRIED OUT, NOR WITH ALTERNATIVE REAGENTS. IN ADDITION, THE LIMITATIONS OF THE PROCEDURE FROM THE IFU OF DG GEL 8 ANTI-IGG CARD (REF. 210394) STATES THAT INVESTIGATIVE TECHNIQUES MAY BE CONDUCTED: "NO SINGLE METHOD IS ABLE TO DETECT ALL UNEXPECTED ANTIBODIES. THE OPTIMUM REACTION CONDITIONS (E.G., SAMPLE VOLUME, INCUBATION TIME) MAY VARY FOR DIFFERENT ANTIBODY SPECIFICITIES. FOR SCREENING AND IDENTIFICATION OF UNEXPECTED ANTIBODIES, CROSSMATCH AND AUTOCONTROL TESTS, INCREASING THE VOLUME OF SERUM OR PLASMA FROM 25 UL TO 50 UL AS WELL AS EXTENDING THE INCUBATION TIME FROM 15 TO 30 MINUTES IS ACCEPTABLE. THIS VARIATION IN THE CONCENTRATION OF ANTIBODIES BRINGS THE ANTIGEN/ANTIBODY RATIO DOWN AND MAY IMPROVE THE DETECTION OF ANTIBODIES AT VERY LOW CONCENTRATIONS". BASED ON ALL THE ELEMENTS FROM THE INVESTIGATION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTION WITH CELL 2 (DONOR M8357AM) OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09, 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. IT SHALL BE NOTED THAT NEGATIVE REACTIONS WERE ALSO OBTAINED WITH E+ IDENTIFICATION PANEL RRBCS (HOMOZYGOUS AND HETEROZYGOUS) AND ONLY TWO HOMOZYGOUS E+ IDENTIFICATION PANEL RRBCS REACTED, WITH A 1+ WEAK POSITIVE RESULT; HOWEVER, THESE TWO RRBCS HAD A LONGER EXPIRY DATE (EXP. 2026-05-23) THAN THE RRBCS THAT DID NOT REACT (EXP. 2026-05-09). THIS FURTHER SUPPORTS THE HYPOTHESIS OF A LOW-TITER ANTI-E ANTIBODY IN THE PATIENT SAMPLE. NO SINGLE METHOD IS ABLE TO DETECT ALL IRREGULAR ANTIBODIES. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCT SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE (ANTI-E) ANTIBODY SCREENING RESULTS FOR ONE PATIENT SAMPLE, OBTAINED WITH CELL 2 (E+E-, DONOR (B)(6) OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09. THE SAMPLE (B)(6) ORIGINATES FROM AN 80-YEAR-OLD FEMALE PATIENT WHO HAD A THORACIC ENDOVASCULAR AORTIC REPAIR ON (B)(6) 2026. THE PATIENT HAD A HISTORY OF ANTI-K, AND AN ANTI-E WAS IDENTIFIED ON (B)(6) 2026. MULTIPLE TRANSFUSIONS OF PLATELETS AND RBC UNITS OCCURRED BETWEEN (B)(6) 2026. BASED ON THE INFORMATION AND DOCUMENTATION PROVIDED: ON (B)(6) 2026, SAMPLE (B)(6) WAS COLLECTED AND TESTED ON ERYTRA EFLEXIS 910 (SN (B)(6) AT 11H58 FOR ANTIBODY SCREENING USING SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643526007, EXP. 2026-05-09, ON DG GEL 8 ANTI-IGG CARD, LOT 25617.1, EXP. 2026-07-31. WHILE CELL 1 (E-; K+K+) GAVE A 1+ REACTION, THE CELL 2 (E+E-; K-) WAS INTERPRETED AS NEGATIVE - NO REACTIVITY FOR THE HOMOZYGOUS E+ CELL. ANTIBODY IDENTIFICATION WAS PERFORMED AT 13H20 ON THE SAME INSTRUMENT AND WITH THE SAME CARD LOT, USING DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617026008, EXP. 2026-05-23: CELL 1 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 2 (E-; K+K+) WAS INTERPRETED AS 1+, CELL 3 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 4 (E+E+; K-) WAS INTERPRETED AS NEGATIVE - NO REACTIVITY FOR THE HETEROZYGOUS E+ CELL, SHOWING DOSAGE. CELL 5 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 6 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 7 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 8 (E-; K+K+) WAS INTERPRETED AS 1+, CELL 9 (E+E-; K-) WAS INTERPRETED AS 1+, CELL 10 (E+E-; K-) WAS INTERPRETED AS 1+, CELL 11 (E-; K-) WAS INTERPRETED AS NEGATIVE, AUTOCONTROL WAS 1+. ADDITIONAL ANTIBODY IDENTIFICATION WAS PERFORMED AT 14H21 ON THE SAME INSTRUMENT USING DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026007, EXP. 2026-05-09, ON DG GEL 8 ANTI-IGG CARD, LOT 26601.1, EXP. 2026-11-30: CELL 1 (E-; K-) WAS INTERPRETED AS NEGATIVE , CELL 2 (E-; K+K+) WAS INTERPRETED AS 1+, CELL 3 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 4 (E+E+; K-) WAS INTERPRETED AS NEGATIVE - NO REACTIVITY FOR THE HETEROZYGOUS E+ CELL, CELL 5 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 6 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 7 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 8 (E-; K+K+) WAS INTERPRETED AS "?" AND MODIFIED TO W+ BY THE OPERATOR, CELL 9 (E-; K-) WAS INTERPRETED AS NEGATIVE, CELL 10 (E+E-; K-) WAS INTERPRETED AS NEGATIVE - NO REACTIVITY FOR HOMOZYGOUS E+ CELL, CELL 11 (E+E-; K-) WAS INTERPRETED AS NEGATIVE - NO REACTIVITY FOR HOMOZYGOUS E+ CELL. POLYSPECIFIC AND IGG DAT TESTING WAS ALSO PERFORMED ON THE SAME DAY USING GRIFOLS ANTI-HUMAN GLOBULIN ANTI-IGG, C3D, POLYSPECIFIC REAGENT LOT 023000 (EXP. 2027-02-28) AND GRIFOLS ANTI-HUMAN GLOBULIN ANTI-IGG REAGENT LOT 412000 (EXP. 2027-02-28), RESPECTIVELY: DAT POLYSPECIFIC RESULTED IN A POSITIVE (1+) REACTION DAT IGG SHOWED A NEGATIVE RESULT. NO ADDITIONAL TESTING WAS CARRIED OUT AS PER INFORMATION AND DOCUMENTATION PROVIDED. THE CUSTOMER IDENTIFIED AN ANTI-E ANTIBODY IN ADDITION TO THE PREVIOUSLY KNOWN ANTI-K. HOWEVER, THE 1+ REACTIONS WITH HOMOZYGOUS E+ RRBCS OBTAINED IN THE IDENTIFICATION PANEL EXPIRING 2025-05-23, WERE NOT OBSERVED IN THE SCREENING AND IDENTIFICATION PANELS EXPIRING 2026-05-09. ACCORDING TO L2 INVESTIGATION, REVIEW OF THE INSTRUMENT LOGS SHOWED NO ERRORS DURING THE TIME OF TESTING OF THE SAMPLE, RULING OUT THE INSTRUMENT AS A POTENTIAL ROOT CAUSE OF THE UNEXPECTED NEGATIVE REACTIONS. A REVIEW OF THE PRE-PROCESSING INTEGRITY CHECK RAW IMAGE FILES SHOWED BUFFER SPLASHING AND GEL DISPLACEMENT IN MICROTUBE WELLS 1 - 4 OF IGG CARDS (B)(6), WHICH WERE USED IN TESTING WITH DATA-CYTE PLUS 0.8% LOT 610026007 (CELLS 1 - 4 AND 9 - 11). CELLS 4, 10 AND 11 ARE ALL E+ RRBCS, SUGGESTING THAT GEL CARD INTEGRITY COULD NOT BE RULED OUT AS THE CAUSE OF THE UNEXPECTED REACTIONS. ALL OTHER INTEGRITY CHECK RAW IMAGES WERE ACCEPTABLE. REVIEW OF THE POST-PROCESSING FINAL READ RAW IMAGES SHOWED REACTIONS THAT AGREE WITH THE INSTRUMENT GRADING ALGORITHM, RULING OUT THE READER AS A POSSIBLE CAUSE OF THE UNEXPECTED REACTIONS. THE SAMPLE INCUBATION TIMES WERE 15 MINUTES, AND AN APPROPRIATE AMOUNT OF PLASMA WAS DISPENSED INTO THE WELLS. COULD NOT RULE OUT SAMPLE RELATED ISSUES AS THE CAUSE OF THE UNEXPECTED REACTIONS SINCE THE SAMPLE ONLY TESTED 1+ POSITIVE ON TWO OUT OF THE FIVE HOMOZYGOUS E+ RRBCS TESTED, AND NEGATIVE FOR THE TWO HETEROZYGOUS AND THE OTHER THREE HOMOZYGOUS E+ RRBCS, SUGGESTING THAT THE ANTI-E ANTIBODY IS AT OR NEAR THE LIMIT OF DETECTION OF THE GRIFOLS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116062 SEARCH-CYTE PLUS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 643526007 07640137340377

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female