DATA-CYTE PLUS 0.8%
Report
- Report Number
- 3002806769-2025-00001
- Event Type
- Malfunction
- Date Received
- January 10, 2025
- Date of Event
- December 11, 2024
- Report Date
- January 10, 2025
- Manufacturer
- MEDION GRIFOLS DIAGNOSTICS AG,
- Product Code
- QHT
- UDI-DI
- 07640137340285
- PMA / PMN Number
- BL103898
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
THE MANUFACTURING DOCUMENTATION OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21, AND DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024024, EXP. 2025-01-04, 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, ALL FYB+ CELLS FROM BOTH CLAIMED PRODUCTS GAVE POSITIVE (2+ TO 3+) REACTIONS WHEN TESTED WITH ANTI-FYB FOR DG GEL, REF. 213207, LOT 656024011A, EXP. 2025-12-31. CELL 9 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21, WAS PREPARED WITH DONOR (B)(6). THE ENTRY TYPING OF THIS DONOR WAS REVIEWED AND NO DEVIATIONS WERE FOUND. THE DONOR WAS INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-FYB AND 3+ REACTIONS WERE OBTAINED. THE HISTORY OF DONOR (B)(6) WAS ALSO REVIEWED. DONOR (B)(6) WAS USED IN THE MANUFACTURING OF CELL 9 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21, AS WELL AS IN FIVE OTHER FINISHED PRODUCTS IN THREE DIFFERENT MANUFACTURING CAMPAIGNS. BESIDES THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG AGAINST A CELL MANUFACTURED WITH DONOR (B)(6). CELL 7, CELL 8 AND CELL 9 OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024024, EXP. 2025-01-04, WERE PREPARED WITH DONORS (B)(6), RESPECTIVELY. THE ENTRY TYPING OF THESE DONORS WAS REVIEWED AND NO DEVIATIONS WERE FOUND. THE DONORS WERE INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-FYB. THE REACTIONS RANGED BETWEEN 2+ AND 3+ REACTIONS. THE HISTORY OF DONORS (B)(6) WAS ALSO REVIEWED. DONOR (B)(6) ARE NEW DONORS. THEIR FIRST AND ONLY USE HAS BEEN IN THE MANUFACTURING OF CELL 7 AND CELL 8, RESPECTIVELY, OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024024, EXP. 2025-01-04. BESIDES THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG AGAINST A CELL MANUFACTURED WITH DONORS (B)(6). DONOR (B)(6) WAS USED IN THE MANUFACTURING OF CELL 9 OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024024, EXP. 2025-01-04, AS WELL AS IN NINE OTHER FINISHED PRODUCTS IN TEN DIFFERENT MANUFACTURING CAMPAIGNS. BESIDES THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG AGAINST A CELL MANUFACTURED WITH DONOR (B)(6). INTERNAL STABILITY RECORDS OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21, AND DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024024, EXP. 2025-01-04, WERE REVIEWED. THE EXPECTED RESULTS WERE OBTAINED AT ALL TESTED TIME POINTS. ALL FYB+ CELLS FROM BOTH CLAIMED PRODUCTS GAVE POSITIVE (2+ TO 3+) REACTIONS WHEN TESTED WITH ANTI-FYB FOR DG GEL, REF. 213207, LOT 656024011A, EXP. 2025-12-31, THROUGHOUT THE PRODUCTS SHELF-LIFE. BASED ON THE ELEMENTS ABOVE AND ALSO CONSIDERING THAT THE ANTI-FYB IN THE PATIENT SAMPLE DID NEITHER REACT IN TUBE METHOD WITH PEG ENHANCER USING COMPETITOR REAGENTS (QUOTIENT ALBACYTE REAGENT, LOT V278519 & V278521, EXP. 2024-12-30), THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS IN SAMPLE "(B)(6)" WITH FYB+ CELLS FROM DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21, AND DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024024, EXP. 2025-01-04, IS SAMPLE RELATED, POINTING TO LOW-TITER ANTI-FYB IN THE PATIENT PLASMA WITH FYB SPECIFICITY THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THESE LOW ANTI-FYB LEVELS 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 (NOTE: AT LEAST ONE C-FYB+ CELL (I.E. CELL 8 (C-; FYA-B+) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21) OF THE CLAIMED PRODUCTS DID REACT WITH THE PATIENT SAMPLE). NO SINGLE METHOD IS ABLE TO DETECT ALL IRREGULAR ANTIBODIES. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCTS DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21, AND DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024024, EXP. 2025-01-04. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.
A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION RESULTS FOR ANTI-FYB ON ERYTHRA EFLEXIS FOR ONE PATIENT SAMPLE (ID "(B)(6)"), OBTAINED WITH CELL 9 (C-; FYA-B+, DONOR (B)(6)) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21 (UDI: (B)(4)), AS WELL AS WITH CELL 7 (C-; FYA-B+, DONOR (B)(6)), CELL 8 (C-; FYA+B+, DONOR (B)(6)) AND CELL 9 (C+WC+; FYA+B+, DONOR (B)(6)) OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024024, EXP. 2025-01-04 (UDI: (B)(4)). THE PATIENT IS A 77-YEAR-OLD FEMALE DIAGNOSED WITH ACUTE URINARY TRACT INFECTION (UTI) AND WHO HAD A TRANSFUSION ON (B)(6) 2024 BUT NO ANTIBODY HISTORY. THE CUSTOMER CLAIMED THAT FOLLOWING POSITIVE ANTIBODY SCREENING AND ANTIBODY IDENTIFICATION, AN ANTI-C WAS IDENTIFIED WITH ADDITIONAL REACTIVITY WITH ONE CELL THAT DID NOT MATCH ANTI-C. SAMPLE "(B)(6)" WAS COLLECTED ON (B)(6) 2024 AND TESTED FOR ANTIBODY SCREENING ON ERYTHRA EFLEXIS (B)(6) AT 23H48 WITH SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724024, EXP. 2025-01-04, ON DG GEL 8 ANTI-IGG CARD, LOT *020.01, EXP. 2025-04-30. WHILE CELL 1 (C-; FYB-) REACTED NEGATIVE, THE CELL 2 (C-C+; FYA-B+) AND CELL 3 (C-C+; FYA+B+) BOTH REACTED POSITIVE (2+). THE SAMPLE WAS THEN PROCESSED FOR ANTIBODY IDENTIFICATION ON THE SAME INSTRUMENT ON (B)(6) 2024 AT 00H36 WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21, USING THE SAME CARD LOT (DG GEL 8 ANTI-IGG CARD, LOT *020.01, EXP. 2025-04-30), AND NEGATIVE REACTIONS WERE OBTAINED ON CELL 7 (C-; FYB-) AND CELL 9 (C-; FYA-B+), HOWEVER SOME AGGLUTINATES AMONG THE GEL CAN BE OBSERVED FOR THE CELL 9. THE CELL 1 (C-C+; FYA-B+), CELL 2 (C-C+, FYA+B+), CELL 4 (C-C+, FYA-B+), CELL 5 (C-C+, FYB-) AND CELL 11 (C-C+, FYA-B+) GAVE 2+ REACTIONS, WHILE CELL 6 (C-C+; FYB-) AND CELL 10 (C-C+; FYB-) GAVE 1+ REACTIONS. THE CELL 3 (C+C+; FYB-) AND CELL 8 (C-; FYA-B+) WERE INTERPRETED AS "?" BY THE INSTRUMENT BUT MODIFIED TO 1+ BY THE OPERATOR. THE AUTOCONTROL WAS NEGATIVE. THE SAMPLE WAS TESTED AGAIN FOR ANTIBODY IDENTIFICATION ON THE SAME INSTRUMENT ON (B)(6) 2024 AT 01H21 WITH DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024024, EXP. 2025-01-04, USING THE SAME CARD LOT (DG GEL 8 ANTI-IGG CARD, LOT *020.01, EXP. 2025-04-30). POSITIVE 3+ REACTION WAS OBTAINED FOR CELL 5 (C-C+; FYB-) AND 2+ REACTIONS WERE OBSERVED FOR CELL 1 (C-C+; FYA-B+), CELL 2 (C-C+; FYB-) AS WELL AS CELL 4 (C-C+; FYA+B+). BOTH CELL 3 (C+C+; FYA+B+) AND CELL 6 (C-C+; FYB-) GAVE 1+ REACTIONS. NEGATIVE RESULTS WERE OBTAINED FOR CELL 7 (C-; FYA-B+), CELL 8 (C-; FYA+B+) AND CELL 9 (C+WC+; FYA+B+), HOWEVER SOME AGGLUTINATES AMONG THE GEL CAN BE OBSERVED. THE AUTOCONTROL WAS NEGATIVE AS WELL. ON (B)(6) 2024, THE CUSTOMER ALSO PERFORMED ANTIBODY SCREENING IN TUBE TECHNIQUE USING SEARCH-CYTE TCS 3%, REF. 213631, LOT 644024023, EXP. 2024-12-21, WITH LISS AND PEG. IN LISS, ALL THREE SCREENING CELLS REACTED NEGATIVE FOR IS, 37°C AND AHG. HOWEVER, WHEN THE TEST WAS PERFORMED WITH PEG ENHANCER (NO INFORMATION ABOUT REAGENT AND LOT USED), ALL SCREENING CELLS REACTED NEGATIVE AS WELL WITH IMMEDIATE SPIN (IS) BUT IN AHG THE CELL 2 (C-C+; FYB-) AND CELL 3 (C-C+; FYB-) GAVE A 2+ REACTION, WHILE CELL 1 (C-; FYA-B+) REACTED NEGATIVE. THE SAMPLE WAS TESTED FOR ANTIBODY IDENTIFICATION IN TUBE METHOD USING QUOTIENT ALBACYTE REAGENT, LOT V278519 & V278521, EXP. 2024-12-30, WITH PEG ENHANCER (NO INFORMATION ABOUT REAGENT AND LOT USED). IN IS, ALL TEN IDENTIFICATION CELLS REACTED NEGATIVE. IN AHG, CELLS 3 TO 10 (ALL C+) WERE ALL INTERPRETED AS 2+ EXCEPT CELL 3 WHICH GAVE A 1+ REACTION. THE LAST TWO CELLS THAT WERE NEGATIVE FOR THE C ANTIGEN CELL 1 (C-; FYA+B+) AND CELL 2 (C-; FYA-B+) GAVE NEGATIVE REACTIONS. AUTOCONTROL WAS NEGATIVE IN IS AND AHG. BASED ON THE INFORMATION IN THE WORK ORDER, AN ANTI-C WAS IDENTIFIED WITH ADDITIONAL REACTIVITY WITH ONE CELL THAT DID NOT MATCH ANTI-C (I.E. CELL 8 (C-; FYA-B+) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024023, EXP. 2024-12-21). THE SAMPLE WAS SENT TO THE CUSTOMER REFERENCE LAB (ONEBLOOD), AND THEIR REPORT STATED THAT ANTI-C AND ANTI-FYB WERE IDENTIFIED, REACTIVE IN GEL COLUMN AGGLUTINATION AND PEG ENHANCEMENT MEDIA. DAT IN GEL (TGG) AND TUBE (IGG, C3) WAS NEGATIVE. ON (B)(6) 2024, THE CUSTOMER TESTED THE PATIENT SAMPLE IN MANUAL METHOD WITH SELECTED ORTHO 0.8% CELLS FROM EXPIRED PANEL A, LOT VRA442, EXP. 2023-10-31, USING GRIFOLS DG GEL 8 ANTI-IGG CARDS (LOT NOT SPECIFIED) TO CONFIRM ANTI-FYB ANTIBODY. CELL 1 (C-; FYB-) WAS NEGATIVE, CELL 2 (C-; FYA-B+) AND CELL 11 (C-; FYA-B+) GAVE BOTH A 2+ REACTION, AND CELL 4 (C-C+; FYB-) WAS INTERPRETED AS 3+. ACCORDING TO L2 INVESTIGATION, REVIEW OF THE INSTRUMENT LOGS SHOWED NO ERRORS AT THE TIME OF TESTING AND DAILY QUALITY CONTROL TESTING PERFORMED AS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1324010 | DATA-CYTE PLUS 0.8% | REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION | QHT | MEDION GRIFOLS DIAGNOSTICS AG, | N/A | 610024023 | 07640137340285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female |