SEARCH-CYTE PLUS 0.8%

Report

Report Number: 3002806769-2025-00002
Event Type: Malfunction
Date Received: March 19, 2025
Date of Event: February 27, 2025
Report Date: March 19, 2025
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

I. DOCUMENTARY INVESTIGATION: THE MANUFACTURING DOCUMENTATION OF SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15, 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 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 PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15, WAS PREPARED WITH DONOR (B)(6). THE ENTRY TYPING OF THE DONOR WAS REVIEWED AND NO DEVIATIONS WERE FOUND. THE DONOR WAS INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT POLYCLONAL ANTI-C AND STRONG POSITIVE REACTIONS WERE OBTAINED. THE HISTORY OF DONOR (B)(6) WAS ALSO REVIEWED. DONOR (B)(6) WAS USED IN THE MANUFACTURING OF CELL 2 OF SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15, AS WELL AS IN FOUR OTHER FINISHED PRODUCTS IN TWO DIFFERENT MANUFACTURING CAMPAIGNS. BESIDES THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER SIMILAR COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG AGAINST A CELL MANUFACTURED WITH DONOR (B)(6). INTERNAL STABILITY RECORDS OF SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15, WERE REVIEWED AND THE EXPECTED RESULTS WERE OBTAINED AT ALL TIME POINTS. II. INVESTIGATIVE TESTING: TITRATION OF A SINGLE SOURCE POLYCLONAL ANTI-C WITH SELECTED HOMOZYGOUS (R2R2 - INCLUDING THE CLAIMED CELL 2 OF SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15) WAS DONE IN MANUAL METHOD IN OUR QUALITY CONTROL LABORATORY AT MEDION GRIFOLS DIAGNOSTICS AG. THE FIVE HOMOZYGOUS R2R2 C+ RRBCS TESTED GAVE A TITER BETWEEN 1:2'048 (CELL FROM COMPETITOR) AND 1:4'096 (INCLUDING THE CLAIMED CELL 2 AS WELL AS THE SINGLE R2R2 IDENTIFICATION CELL 10 WHICH REACTED 1+ WHEN TESTED BY THE CUSTOMER). THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY OF THE CLAIMED CELL AND DO NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL C ANTIGEN EXPRESSION OF THE CLAIMED CELL 2 OF SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15. BASED ON ALL THE ELEMENTS, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS WITH CELL 2 (DONOR (B)(6)) OF SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15, IS SAMPLE RELATED, POINTING TO A LOW TITER ANTI-C IN THE PATIENT PLASMA THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS ANTI-C EITHER SHOWS SPECIAL CHARACTERISTICS AND/OR IS AT A LEVEL BELOW THE THRESHOLD TO CAUSE TRANSFUSION REACTION, CONSIDERING THAT THE PATIENT WAS TRANSFUSED WITH TWO BLOOD UNITS THAT WERE POSITIVE FOR C ANTIGEN AND DID NOT EXPERIENCE ANY TRANSFUSION REACTIONS. THIS LOW ANTI-C LEVEL IN THE PATIENT PLASMA SAMPLE, IN COMBINATION WITH ITS CHARACTERISTICS AS WELL AS WITH NATURALLY OCCURRING VARIATIONS IN THE ANTIGEN DENSITY OF RED BLOOD CELLS, MAY BE THE CAUSE OF THE UNEXPECTED RESULT OBSERVED BY THE CUSTOMER. NO SINGLE METHOD IS ABLE TO DETECT ALL IRREGULAR ANTIBODIES. THE CLAIMED CELL SHOWS COMPARABLE TITER AS TO OTHER C-C+ CELLS IN INTERNAL INVESTIGATIONS, AND SIMILAR RESULTS WERE OBTAINED BY THE CUSTOMER WITH NEXT LOT OF SCREENING PANEL SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525004, EXP. 2025-03-29, WHICH ALL DOES FURTHER NOT SUPPORT AN ABNORMALITY WITH THE C ANTIGEN EXPRESSION IN THE CLAIMED RRBC. ACCORDING TO THE LITERATURE (MOLLISON'S BLOOD TRANSFUSION IN CLINICAL MEDICINE, 12TH EDITION (2015), HARVEY G. KLEIN AND DAVID J. ANSTEE; PAGE 170 "NUMBERS OF C, E, AND E ANTIGEN SITES PER RED CELL"), MASOUREDIS ET AL. DESCRIBED IN 1976 THEIR INVESTIGATION ABOUT THE NUMBERS OF C, E, AND E ANTIGEN SITES USING POLYCLONAL IGG ANTIBODIES AND FOUND THAT FOR "C SITES: DCE/DCE CELLS, 31 500; DCE/DCE CELLS, 24 000". MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCT SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15. 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 2 (C-C+, DONOR (B)(6)) OF SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15. ACCORDING TO THE INFORMATION IN THE WORK ORDER, THE CUSTOMER RECEIVED THE PATIENT SAMPLE "(B)(6)" FROM ANOTHER (RURAL) SISTER SITE FOLLOWING POSITIVE ANTIBODY SCREENING RESULTS FOR CONFIRMATION AND ANTIBODY IDENTIFICATION, ALONG WITH SEGMENTS FROM FOUR BLOOD UNITS (B)(4) AVAILABLE IN THE RURAL SISTER SITE. THE SAMPLE WAS COLLECTED ON (B)(6) 2025 AND ORIGINATES FROM A 49-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH CERVICAL CANCER AND WHO RECEIVED TRANSFUSIONS ON (B)(6) 2024 AS WELL AS ON (B)(6)2025. AN ANTI-C WAS IDENTIFIED DURING ANTIBODY IDENTIFICATION USING DATA-CYTE PLUS 0.8%, REF. (B)(4), LOT 610025003, EXP. 2025-03-15. ALL TESTING WAS PERFORMED ON (B)(6) 2025 AT CUSTOMER SITE. THE CUSTOMER ORDERED ABORH TYPING AS WELL AS ANTIBODY SCREENING AND IDENTIFICATION ON THE SAME INSTRUMENT AT THE SAME TIME: - SAMPLE "(B)(6)" WAS TESTED FOR ABORH TYPING AT 03H24 ON ERYTRA EFLEXIS SN (B)(6)(SOFTWARE VERSION 3.2.0) USING DG GEL 8 ADB CARD, LOT *012.01, EXP. 2025-08-31, FOR FORWARD TEST, AND REVERSE-CYTE A1, B 0.8%, REF. (B)(4), LOT 641425006, EXP. 2025-03-15, ON DG GEL 8 NEUTRAL CARD, LOT *020.01, EXP. 2025-07-31, FOR REVERSE GROUPING. THE RESULTS OF THE FORWARD TEST WERE O POSITIVE (A: -, B: -, D: 4+, CTL: -) AND REVERSE GROUPING CONFIRMED THE O GROUP, WITH 4+ REACTION WITH BOTH A1 AND B CELLS. - ANTIBODY SCREENING WAS PERFORMED AT 03H35 USING SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15, ON DG GEL 8 ANTI-IGG CARD, LOT *029.01, EXP. 2025-05-31, AND BOTH CELLS REACTED NEGATIVE; THE CLAIMED HOMOZYGOUS C+ CELL 2 WAS INTERPRETED AS NEGATIVE, BUT A FEW AGGLUTINATES COULD BE OBSERVED IN THE GEL COLUMN. - ANTIBODY IDENTIFICATION WAS PERFORMED AT 03H45 USING DATA-CYTE PLUS 0.8%, REF. (B)(4), LOT 610025003, EXP. 2025-03-15, ON THE SAME CARD LOT. THE RESULTS OBTAINED WERE MATCHING ANTI-C. AUTOCONTROL WAS NEGATIVE. THE CUSTOMER INDICATED THAT WHEN THE ABORH TYPING AND ANTIBODY SCREENING RESULTS WERE AVAILABLE, THEY WERE VERIFIED AND RELEASED. THE RURAL SISTER SITE SAW THESE RESULTS AND BASED ON THE NEGATIVE SCREENING RESULTS FROM THE CUSTOMER SITE, THEY DID NOT EXPECT ANTIBODY IDENTIFICATION RESULTS AND PERFORMED IMMEDIATE SPIN CROSSMATCH (IS XM) OF TWO BLOOD UNITS (B)(4) AND RELEASED THEM FOR TRANSFUSION FOLLOWING NEGATIVE (COMPATIBLE) RESULTS. THE ANTIBODY IDENTIFICATION RESULTS WERE RELEASED LATER AND BASED ON THE POSITIVE RESULTS MATCHING AN ANTI-C, BEING DISCREPANT WITH THE ANTIBODY SCREENING RESULTS, THE MEDICAL DIRECTOR AT CUSTOMER SITE AS WELL AS THE RURAL SISTER SITE WERE INFORMED. AN INVESTIGATION WAS CONDUCTED AT CUSTOMER SITE, AND IT WAS IDENTIFIED THAT BOTH TRANSFUSED BLOOD UNITS (B)(4) WERE POSITIVE FOR THE C ANTIGEN. CROSSMATCH TESTING WAS THEN PERFORMED FOR THE FOUR BLOOD UNIT SEGMENTS (B)(4) THEY HAD FROM THE RURAL SISTER SITE. IMMEDIATE SPIN CROSSMATCH (IS XM) TESTING WAS PERFORMED ON THE SAME INSTRUMENT AT 05H00 ON DG GEL 8 NEUTRAL CARD, LOT *020.01, EXP. 2025-07-31, AND THE RESULTS WERE NEGATIVE (COMPATIBLE) FOR ALL FOUR BLOOD UNITS TESTED. THE CUSTOMER STATED AND LATER CONFIRMED THAT EVEN THOUGH THE PATIENT DID RECEIVE TWO BLOOD UNITS THAT WERE POSITIVE FOR THE C ANTIGEN, THE PATIENT DID NOT EXPERIENCE ANY TRANSFUSION REACTION AND IS DOING OKAY. CUSTOMER REPEATED THE ANTIBODY SCREENING TESTING ON THE SAME INSTRUMENT AT 10H49 USING THE SAME REAGENTS INCLUDING THE CLAIMED SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525003, EXP. 2025-03-15, AND THE SAME NEGATIVE RESULTS WERE OBTAINED. DAT TESTING WAS PERFORMED ON THE EFLEXIS INSTRUMENT AT 12H15 USING DG GEL 8 DIRECT COOMBS CARD, LOT *001.01, EXP. 2026-05-31, AND WAS NEGATIVE (IGG/C3D, IGG, C3D AND CTL). UPON REQUEST, THE CUSTOMER PERFORMED ADDITIONAL ANTIBODY SCREENING ON INSTRUMENT AT 14H25 WITH THE CLAIMED PRODUCT, BUT WITH 50 L PLASMA INSTEAD OF 25 L, AS WELL AS IN MANUAL METHOD WITH 25 L PLASMA AND EXTENDED 30 MIN INCUBATION TIME. FOR BOTH TESTING, NEGATIVE SCREENING RESULTS WERE OBSERVED. THE CUSTOMER ALSO TESTED IN MANUAL METHOD (25 L PLASMA, 30 MIN INCUBATION) THE EXPIRED PREVIOUS LOT OF SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525001, EXP. 2025-02-15, AND THE CELL 2 (C-C+) REACTED POSITIVE. THE SAME DG GEL 8 ANTI-IGG CARD LOT WAS USED AS IN THE PREVIOUS TESTING. ACCORDING TO L2 INVESTIGATION, REVIEW OF THE RAW IMAGE FILE SHOWED NO GEL DISPLACEMENT OR BUFFER SPLASHING IN THE CARDS USED FOR TESTING. INTEGRITY CHECK IMAGES APPEARED ACCEPTABLE, AND RESULTS READ IMAGES SHOWED AGGLUTINATION PATTERNS THAT ARE VISUALLY CONSISTENT WITH THE ALGORITHM CALLS. THE INSTRUMENT LOGS SHOWED NO ERRORS RELATED TO THE REPORTED TESTING (A SMALL NUMBER OF INSUFFICIENT VOLUME AND CARD MOVEMENT ERRORS ARE NOTED). DAILY QC PASSED THE DAY OF TESTING, AND NO WARNING OR INCIDENT ARE NOTED ON THE RESULTS. ON (B)(6) 2025, THE CUSTOMER RECEIVED A NEW LOT OF SEARCH-CYTE PLUS 0.8%, REF. (B)(4), LOT 643525004, EXP. 2025-03-29, UPON THEIR REQUEST. THEY RETESTED THE PATIENT SAMPLE ON (B)(6) 2025 AT 15H02 ON THE SAME INSTRUMENT WITH THE SAME DG GEL 8 ANTI-IGG CARD LOT *029.01, EXP. 2025-05-31, AND BOTH SCREENING CELLS WERE INTERPRETED AS NEGATIVE, INCLUDING THE CELL 2 (C-C+, DONOR (B)(6)). NO SAMPLE WAS AVAILABLE FOR THE INVESTIGATION. THE SERUM/PLASMA HAS BEEN EXHAUSTED WITH THE INVESTIGATIONAL TESTING AT CUSTOMER SITE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
796047	SEARCH-CYTE PLUS 0.8%	REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION	QHT	MEDION GRIFOLS DIAGNOSTICS AG,	N/A	643525003	07640137340377

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR	Female