BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE TCS 0.8%

    MDR report key: 20585440 · Received November 1, 2024

    Report

    Report Number
    3002806769-2024-00010
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 1, 2024
    Report Date
    November 1, 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

    INVESTIGATION PERFORMED BY GRIFOLS SUPPORT ORGANIZATION: ACCORDING TO L2 INVESTIGATION, RAW IMAGE FILES OF ALL TESTING PERFORMED ON GRIFOLS INSTRUMENTS SHOWED NO EVIDENCE OF COMPROMISED GEL OR BUFFER SPLASHING. POST PROCESSING IMAGES SHOWED REACTIVITY BELOW THE THRESHOLD IN THE ORIGINAL TESTING ON (B)(6) 2024 ON CELL 3 (E-; C-C+, DONOR (B)(6) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12. LOG FILES REVIEW SHOWED EXPECTED OPERATION OF THE INSTRUMENT AND NO ERRORS DURING THE PROCESSING OF THE INVESTIGATED SAMPLES. QC ALSO PASSED ON THE DAYS OF TESTING. REVIEW OF DATA PROVIDE BY CUSTOMER: THE CUSTOMER STATED THAT AN ANTI-E AND ANTI-C WERE IDENTIFIED ON THE SAMPLE (ID "(B)(6)". ON (B)(6) 2024, POSITIVE REACTIONS (1+ TO 2+) WERE OBTAINED WITH HOMOZYGOUS CELL 2 (E+; C-C+) AND CELL 3 (E-; C-C+) OF ORTHO PANEL 3 (0.8%), LOT VSS590, EXP. 2024-10-29, AS WELL AS WITH HOMOZYGOUS CELL 7 (E-;C-C+) OF AN ORTHO PANEL (REFERENCE AND LOT NUMBER UNKNOWN). ANTIBODY IDENTIFICATION TESTING WAS AGAIN PERFORMED ON THE SAMPLE ON THE SAME DAY AND ON ERYTRA EFLEXIS SN-(B)(6). SAMPLE ID "(B)(6)" WAS TESTED WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024019, EXP. 2024-10-26, USING DG GEL 8 ANTI-IGG CARDS, LOT 24012.01, EXP. 2025-02-28. NEGATIVE REACTIONS WERE OBTAINED WITH HOMOZYGOUS CELL 1 (E-; C-C+), CELL 2 (E-; C-C+), CELL 5 (E-; C-C+), CELL 6 (E-; C-C+), AS WELL AS WITH HETEROZYGOUS CELL 3 (E-; C+C+). POSITIVE REACTIONS (2+) WERE OBTAINED WITH HOMOZYGOUS CELL 4 (E+; C-C+), CELL 10 (E+; C-C+) AND CELL 11 (E+; C-C+). THE AUTOCONTROL GAVE A "?" RESULT WHICH WAS MODIFIED TO A W+ REACTION BY THE OPERATOR. ANTIBODY IDENTIFICATION TESTING WAS AGAIN PERFORMED ON THE SAMPLE ON (B)(6) 2024 AND ON ERYTRA EFLEXIS SN-(B)(6). SAMPLE ID "(B)(6)" WAS TESTED WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024019, EXP. 2024-10-26, USING DG GEL 8 ANTI-IGG CARDS, LOT 24012.01, EXP. 2025-02-28. NEGATIVE REACTIONS WERE OBTAINED WITH HOMOZYGOUS CELL 1 (E-; C-C+), CELL 2 (E-; C-C+), CELL 5 (E-; C-C+), CELL 6 (E-; C-C+), AS WELL AS WITH HETEROZYGOUS CELL 3 (E-; C+C+). POSITIVE REACTIONS (2+) WERE OBTAINED WITH HOMOZYGOUS CELL 4 (E+; C-C+), CELL 10 (E+; C-C+) AND CELL 11 (E+; C-C+). THE AUTOCONTROL GAVE A POSITIVE (1+) RESULT. THESE RESULTS SUGGEST THAT THE MOST LIKELY ROOT CAUSE IS AN ANTI-C ANTIBODY AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM AS ALL HOMOZYGOUS AND HETEROZYGOUS C+ CELLS IN THE GRIFOLS SYSTEM CONSISTENTLY DO NOT REACT WITH THIS SAMPLE. REVIEW OF INCIDENCES DURING THE MANUFACTURING PROCESS BY MANUFACTURER: THE MANUFACTURING DOCUMENTATION OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12, 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 3 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12, WAS PREPARED WITH DONOR (B)(6). THE ENTRY TYPING OF DONOR (B)(6) WAS REVIEWED AND NO DEVIATIONS WERE FOUND. THE DONOR (B)(6) WAS INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-C AND POSITIVE REACTIONS (4+) WERE OBTAINED. THE HISTORY OF DONOR (B)(6) WAS REVIEWED. DONOR (B)(6) WAS USED IN THE MANUFACTURING OF THE CLAIMED SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12, AS WELL AS SIX OTHER FINISHED PRODUCTS IN A DIFFERENT MANUFACTURING CAMPAIGN. FOR THE PRODUCTS MANUFACTURED WITH DONOR (B)(6), A COMPLAINT DATABASE SEARCH WAS PERFORMED, CONCLUDING THAT TO DATE, BESIDE THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY (B)(6) DIAGNOSTICS AG AGAINST A CELL MANUFACTURED WITH DONOR (B)(6). INTERNAL STABILITY RECORDS OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12, WERE REVIEWED. THE EXPECTED RESULTS WERE OBTAINED AT ALL TESTED TIME POINTS. CONCLUSIONS AS A CONCLUSION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS 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 LOW ANTI-C 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. NO SINGLE METHOD IS ABLE TO DETECT ALL IRREGULAR ANTIBODIES. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCTS SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS ON ERYTRA EFLEXIS FOR ONE PATIENT. THIS UNEXPECTED NEGATIVE RESULT WAS OBTAINED ON (B)(6) 2024 (SAMPLE ID "(B)(6)") WITH HOMOZYGOUS CELL 3 (E-; C-C+, DONOR (B)(6) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12. SAMPLE ID "(B)(6)" WAS TESTED FOR ANTIBODY SCREENING ON (B)(6) 2024 ON ERYTRA EFLEXIS SN-(B)(6) WITH SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12, USING DG GEL 8 ANTI-IGG CARDS, LOT 24012.01, EXP. 2025-02-28. CELL 3 (E-; C-C+) WAS INTERPRETED AS NEGATIVE. A 2+ REACTION WAS OBTAINED WITH CELL 2 (E+; C-C+) AS THE SAMPLE CONTAINED AS WELL AS AN ANTI-E ANTIBODY (SEE BELOW). THE CUSTOMER STATED THAT AN ANTI-E AND ANTI-C WERE IDENTIFIED ON THE SAMPLE (ID "(B)(6)". ON (B)(6)2024, POSITIVE REACTIONS (1+ TO 2+) WERE OBTAINED WITH HOMOZYGOUS CELL 2 (E+; C-C+) AND CELL 3 (E-; C-C+) OF ORTHO PANEL 3 (0.8%), LOT VSS590, EXP. 2024-10-29, AS WELL AS WITH HOMOZYGOUS CELL 7 (E-;C-C+) OF AN ORTHO PANEL (REFERENCE AND LOT NUMBER UNKNOWN). SAMPLE ID "(B)(6)" WAS TESTED AGAIN FOR ANTIBODY SCREENING ON (B)(6) 2024 ON ERYTRA EFLEXIS SN-(B)(6) WITH SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12, USING DG GEL 8 ANTI-IGG CARDS, LOT 24012.01, EXP. 2025-02-28. CELL 3 (E-; C-C+) WAS INTERPRETED AS NEGATIVE. A 2+ REACTION WAS OBTAINED WITH CELL 2 (E+; C-C+).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930116 SEARCH-CYTE TCS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY DETECTION QHT MEDION GRIFOLS DIAGNOSTICS AG N/A 644724018 07640137340384

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female