BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE TCS 0.8%

    MDR report key: 20459810 · Received October 16, 2024

    Report

    Report Number
    3002806769-2024-00008
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 16, 2024
    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

    THE INVESTIGATIVE TESTING PERFORMED IN THE QUALITY CONTROL LABORATORY OF MEDION GRIFOLS DIAGNOSTICS AG SHOWED A COMPARABLE TITER BETWEEN THE TESTED HETEROZYGOUS FYA+ RRBCS (INCLUDING CELL 1 OF SEARCH-CYTE TCS (B)(4), REF. (B)(4), LOT 644724016, EXP. 2024-09-14, AS WELL AS CELL 9 AND CELL 10 OF DATA-CYTE PLUS (B)(4), REF. (B)(4), LOT 610024017, EXP. 2024-09-28), WHICH DOES NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL FYA ANTIGEN EXPRESSION OF THESE CELLS AND DOES NOT DEMONSTRATE ANY MALFUNCTION OF CELL 1 OF SEARCH-CYTE TCS (B)(4), REF. (B)(4), LOT 644724016, EXP. 2024-09-14, AS WELL AS CELL 9 AND CELL 10 OF DATA-CYTE PLUS (B)(4), REF. (B)(4), LOT 610024017, EXP. 2024-09-28. THUS, THE INVESTIGATIVE TESTING IS SUPPORTING THE HYPOTHESIS OF THE PRESENCE OF A LOW-TITER ANTI-FYA ANTIBODY IN THE PATIENT PLASMA THAT IS AT THE DETECTION LIMIT OF THE GEL SYSTEM. THE HOMOZYGOUS FYA+ RRBCS TESTED GAVE ALL A TITER OF 1:64, EXCEPT THE CELL 3 (DONOR (B)(6)) OF SEARCH-CYTE TCS (B)(4), REF. (B)(4), LOT 644724016, EXP. 2024-09-14, WHICH SHOWED A TITER OF 1:16. THIS CELL 3 IS AND REMAINS CLEARLY FYA-POSITIVE THROUGHOUT STABILITY AND BEYOND (TITRATION TESTS WERE DONE AFTER RRBC EXPIRY DATE), WHICH SUPPORTS ABSENCE OF MALFUNCTION. HOWEVER, THE TITRATION RESULTS SHOW A DIFFERENCE IN TWO TITERS COMPARED TO ALL OTHER HOMOZYGOUS FYA+ RRBCS TESTED (1:64) AND THE TITER OBTAINED WITH THE CLAIMED CELL 3 (1:16) OF SEARCH-CYTE TCS (B)(4), REF. (B)(4), LOT 644724016, EXP. 2024-09-14, WAS MORE COMPARABLE TO THE ONES OBTAINED WITH HETEROZYGOUS FYA+ RRBCS TESTED. CONSEQUENTLY, EVEN IN ABSENCE OF MALFUNCTION, MEDION GRIFOLS DIAGNOSTICS AG DECIDED TO INACTIVATE DONOR (B)(6) FROM ITS DONOR'S DATABASE SO THAT IT WILL NOT BE USED ANYMORE ON FUTURE OCCASIONS. AS A CONCLUSION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS IS SAMPLE RELATED, POINTING TO A LOW-TITER ANTI-FYA IN THE PATIENT PLASMA THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS LOW ANTI-FYA 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 RESULT OBSERVED BY THE CUSTOMER. NEVERTHELESS, EVEN THE ENTRY FYA TYPING RESULTS OF DONOR (B)(6) USED FOR THE CELL 3 OF SEARCH-CYTE TCS (B)(4), REF. (B)(4), LOT 644724016, EXP. 2024-09-14, AS WELL AS THE STABILITY RESULTS OF THE CLAIMED CELL WERE SIMILAR TO THE ONES OBTAINED WITH THE OTHER CLAIMED CELLS/DONORS, THE INVESTIGATIVE TITRATION RESULTS SHOWED A LOWER TITER FOR THIS CELL. ACCORDINGLY, DONOR (B)(6) WILL BE INACTIVATED IN OUR DONOR DATABASE AND WILL NOT BE USED ANYMORE FOR THE SCREENING/ANTIBODY PANEL PRODUCTS. NO SINGLE METHOD IS ABLE TO DETECT ALL IRREGULAR ANTIBODIES. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCTS SEARCH-CYTE TCS (B)(4), REF. (B)(4), LOT 644724016, EXP. 2024-09-14, AND DATA-CYTE PLUS (B)(4), REF. (B)(4), LOT 610024017, EXP. 2024-09-28.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING AND IDENTIFICATION RESULTS ON ERYTRA EFLEXIS FOR ONE PATIENT, OBTAINED ON (B)(6) 2024 (SAMPLE ID "(B)(6)") WITH CELL 1 (FYA+B+, DONOR ((B)(6)) AND CELL 3 (FYA+B-, DONOR (B)(6)) OF SEARCH-CYTE TCS (B)(4), REF. (B)(4), LOT 644724016, EXP. 2024-09-14 (UDI: (B)(4), AS WELL AS ON (B)(6) 2024 (SAMPLE ID "(B)(6)") WITH HETEROZYGOUS FYA+ CELL 9 (FYA+B+, DONOR (B)(6)) AND CELL 10 (FYA+B+, DONOR ((B)(6)) OF DATA-CYTE PLUS (B)(4), REF. (B)(4), LOT 610024017, EXP. 2024-09-28 (UDI: (B)(4). ACCORDING TO THE INFORMATION IN THE WORK ORDER, BOTH SAMPLES ORIGINATE FROM A 66-YEAR-OLD MALE PATIENT DIAGNOSED WITH TENDINITIS OF THE RIGHT SHOULDER WITH NO RELEVANT MEDICATION. THE PATIENT HAS SCLERODERMA RENAL CRISIS (SRC) BUT DOES NOT HAVE A CURRENT SLA. THE PATIENT RECEIVED MULTIPLE BLOOD PRODUCTS WHEN TRANSFUSED IN 2008 (NO TRANSFUSIONS SINCE 2008). THE CUSTOMER STATED THAT AN ANTI-FYA WAS IDENTIFIED ON THE SAMPLE (ID "(B)(6)") TESTED ON (B)(6) 2024 AND NOT ON THE INITIAL SAMPLE (ID "(B)(6)") TESTED ON (B)(6) 2024; THEY STATED THAT THE PATIENT HAS NOT BEEN TRANSFUSED. SAMPLE ID "(B)(6)" WAS COLLECTED AND TESTED FOR ANTIBODY SCREENING ON (B)(6) 2024 ON ERYTRA EFLEXIS SN(B)(6) (SOFTWARE VERSION 1.2.5, RP VERSION 2.3) WITH SEARCH-CYTE TCS (B)(4), REF. (B)(4), LOT 644724016, EXP. 2024-09-14, USING DG GEL 8 ANTI-IGG CARDS LOT 24009.01 (EXP. 2024-12-31) AND ALL THREE CELLS WERE INTERPRETED AS NEGATIVE INCLUDING CELL 1 (FYA+B+) AND CELL 3 (FYA+B-). NO ANTIBODY IDENTIFICATION TESTING WAS PERFORMED ON THE SAMPLE SINCE THE SCREENING RESULTS WERE NEGATIVE. SAMPLE ID "(B)(6)" WAS COLLECTED AND TESTED ON (B)(6) 2024 ON THE SAME INSTRUMENT WITH SEARCH-CYTE TCS (B)(4), REF. (B)(4), LOT 644724018, EXP. 2024-10-12, USING DG GEL 8 ANTI-IGG CARDS LOT 24012.01 (EXP. 2025-02-28). CELL 1 (FYA-) AND CELL 2 (FYA-) WERE NEGATIVE AND CELL 3 (FYA+B-) WAS INTERPRETED AS POSITIVE (1+) BY THE INSTRUMENT. ANTIBODY IDENTIFICATION WAS THEN PERFORMED WITH DATA-CYTE PLUS (B)(4), REF. (B)(4), LOT 610024017, EXP. 2024-09-28, USING THE SAME LOT OF DG GEL 8 ANTI-IGG CARDS. ALL HOMOZYGOUS FYA+ CELLS (CELL 1, CELL 4, CELL 5 AND CELL 8) WERE INTERPRETED AS 1+. ALL THE OTHER RRBC (INCLUDING THE TWO HETEROZYGOUS FYA+ CELLS (CELL 9 AND CELL 10) WERE NEGATIVE, INCLUDING THE AUTOCONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582004 SEARCH-CYTE TCS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 644724016 07640137340384

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male