SEARCH-CYTE TCS 0.8%

Report

Report Number: 3002806769-2025-00008
Event Type: Malfunction
Date Received: August 20, 2025
Date of Event: July 29, 2025
Report Date: August 20, 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 644725020, EXP. 2025-08-02, 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. CELL 1 AND CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02, WERE PREPARED WITH DONORS M8157AM AND M7730LS, RESPECTIVELY. THE ENTRY TYPING OF BOTH DONORS WAS REVIEWED AND NO DEVIATIONS WERE FOUND. DONORS M8157AM AND M7730LS WERE INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF ANTI-JKA REAGENTS AND POSITIVE REACTIONS WERE OBTAINED. BOTH DONORS M8157AM AND M7730LS ARE NEW DONORS; THEIR FIRST AND ONLY USE HAS BEEN IN THE MANUFACTURING OF TWO FINISHED PRODUCTS AMONG THE SAME MANUFACTURING CAMPAIGN, INCLUDING AS CLAIMED CELL 1 AND CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02, RESPECTIVELY. 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 644725020, EXP. 2025-08-02, NOR INVOLVING ANY OF THE DONORS M8157AM AND M7730LS. INTERNAL STABILITY RECORDS OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02, WERE REVIEWED AND THE EXPECTED RESULTS WERE OBTAINED AT ALL TIME POINTS. II. INVESTIGATIVE TESTING TITRATION OF A SINGLE SOURCE POLYCLONAL ANTI-JKA, WITH SELECTED JKA+ RRBCS, INCLUDING THE CLAIMED CELL 1 (JKA+B-) AND CELL 2 (JKA+B+) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02, AS WELL AS THE CELL 1 (JKA+B-) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, WHICH WAS REACTING POSITIVE WHEN TESTED BY CUSTOMER, BUT ALSO ONE HOMOZYGOUS AND ONE HETEROZYGOUS JKA+ RRBCS FROM ALTERNATIVE MANUFACTURER WITH EXPIRATION DATE CLOSE TO THE CLAIMED PRODUCT, WAS DONE IN MANUAL METHOD IN OUR QUALITY CONTROL LABORATORY AT MEDION GRIFOLS DIAGNOSTICS AG. THE TWO HETEROZYGOUS JKA+ RRBCS (INCLUDING CLAIMED CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02) TESTED GAVE A TITER OF 1:16, AND THE THREE HOMOZYGOUS JKA+ RRBCS TESTED GAVE A TITER BETWEEN 1:8 (CLAIMED CELL 1 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02) AND 1:16. WHILE THE TITER OF THE CLAIMED HOMOZYGOUS CELL 1 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02, SHOWED A TITER OF 1:8 COMPARED TO ALL OTHER JKA+ CELLS WHICH SHOWED A TITER OF 1:16, THE SCORE OBTAINED FOR ITS TITRATION WAS NOT WEAKER AND COMPARABLE TO THE OTHER CELLS. THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY WITH NO SIGNIFICANT DIFFERENCE BETWEEN THE CLAIMED CELL 1 AND CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02, AND THE OTHER TESTED CELLS, INCLUDING THE CELL 1 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, WHICH REACTED POSITIVE WHEN TESTED AT CUSTOMER SITE, BUT ALSO WITH CELLS FROM ALTERNATIVE MANUFACTURER WITH EQUIVALENT EXPIRATION DATE. ACCORDINGLY, THE RESULTS FROM THE INVESTIGATION DOES NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL JKA ANTIGEN EXPRESSION OF THE CLAIMED CELL 1 AND CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02. THUS, THE INVESTIGATIVE TESTING IS SUPPORTING THE HYPOTHESIS OF THE PRESENCE OF A LOW-TITER ANTI-JKA 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 M8157AM) AND CELL 2 (DONOR M7730LS) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02, IS SAMPLE RELATED, POINTING TO A LOW-TITER ANTI-JKA IN THE PATIENT PLASMA WITH JKA SPECIFICITY THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS LOW ANTI-JKA 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 644725020, EXP. 2025-08-02. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.

Description of Event or Problem · 0

A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS FOR ONE PATIENT SAMPLE ("61813820C04") WITH ANTI-JKA, OBTAINED WITH CELL 1 (JKA+B-, DONOR M8157AM) AND CELL 2 (JKA+B+, DONOR M7730LS) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02. NEGATIVE RESULTS WERE ALSO OBTAINED IN MANUAL TESTING. THE CUSTOMER TESTED THE SAMPLE FOR ANTIBODY IDENTIFICATION USING ALTERNATIVE MANUFACTURER REAGENT IN SOLID PHASE METHOD WITH ENHANCEMENT MEDIA AND OBTAINED POSITIVE RESULTS MATCHING THE ANTI-JKA. ACCORDING TO THE INFORMATION PROVIDED: SAMPLE "61813820C04" WAS COLLECTED ON 29 JULY 2025 AND ORIGINATES FROM A 28-YEAR-OLD PREGNANT PATIENT, WITH HISTORY OF ANTI-JKA AS WELL AS A COLD-REACTIVE AUTOANTIBODY. ON 29 JULY 2025, THE SAMPLE WAS PROCESSED ON ERYTRA INSTRUMENT ERY0877 ((B)(6)) AT 21H40 FOR ANTIBODY SCREENING USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02, ON DG GEL 8 ANTI-IGG CARDS, LOT 25005.1, EXP. 2025-12-31, AND ALL SCREENING CELLS REACTED NEGATIVE, INCLUDING CELL 1 (JKA+B-) AND CELL 2 (JKA+B+). THE SAMPLE WAS RETESTED FOR ANTIBODY SCREENING USING THE SAME REAGENTS BUT WITH A DIFFERENT KIT OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725020, EXP. 2025-08-02, AND NEGATIVE REACTIONS WERE ALSO OBTAINED. DUE TO THE PATIENT ANTIBODY HISTORY, ANTIBODY IDENTIFICATION IN SOLID PHASE METHOD WAS PROCESSED ON 31 JULY 2025 USING ALTERNATIVE REAGENTS WITH ENHANCEMENT MEDIA, WITH A 20-MINUTE INCUBATION AT 37°C. THE TESTING RESULTED IN 2+ TO 3+ REACTIONS FOR THE HOMOZYGOUS JKA+ CELLS, AND 1+ TO 2+ REACTIVITY IN THE HETEROZYGOUS JKA+ CELLS FROM THE PANEL. ON 01 AUGUST 2025, THE SAMPLE WAS PROCESSED AT 17H45 FOR ANTIBODY SCREENING ON ERYTRA INSTRUMENT ERY1082 ((B)(6)) USING NEW LOT OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16, ON DG GEL 8 ANTI-IGG CARDS, LOT 25005.1, EXP. 2025-12-31. BOTH JKA+ CELL 1 (JKA+B-) AND CELL 2 (JKA+B-) WERE INTERPRETED AS 1+ BY THE INSTRUMENT, WHILE THE CELL 3 (JKA-) REACTED NEGATIVE, MATCHING THE HISTORICAL ANTI-JKA. UPON REQUEST, THE CUSTOMER RETESTED THE SAMPLE WITH THE NEW LOT OF SCREENING CELLS (SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644725021, EXP. 2025-08-16) ON THE ERY0877. TESTING WAS DONE ON 04 AUGUST 2025 AT 16H33 ON THE SAME CARD LOT, AND SIMILAR RESULTS WERE OBTAINED; CELL 3 (JKA-) WAS NEGATIVE, AND 1+ REACTIONS WERE OBTAINED FOR BOTH HOMOZYGOUS (JKA+B-) CELL 1 AND CELL 2. THE CUSTOMER STATED THAT THEY DID NOT RUN ANTIBODY SCREENING WITH REAGENTS FROM ALTERNATIVE MANUFACTURERS. THEY ONLY RUN ANTIBODY IDENTIFICATION PANELS WITH ALTERNATIVE MANUFACTURER'S REAGENTS. THERE WAS NO SAMPLE LEFT FOR INVESTIGATION/ADDITIONAL TESTING. AS PER L2 INVESTIGATION, REVIEW OF RAW IMAGE SHOWED NO SIGNS OF BUFFER SPLASHING OR GEL DISPLACEMENT, AND POST PROCESSING IMAGES SHOWED REACTIONS THAT AGREE WITH THE INSTRUMENT GRADING ASSIGNMENTS. DAILY QC PASSED ON EACH DAY OF TESTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1244589	SEARCH-CYTE TCS 0.8%	REAGENT RED BLOOD CELLS FOR ANTIBODY DETECTION	QHT	MEDION GRIFOLS DIAGNOSTICS AG,	N/A	644725020	07640137340384

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR	Female