BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE TCS 0.8%

    MDR report key: 20582316 · Received October 31, 2024

    Report

    Report Number
    3002806769-2024-00009
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    September 2, 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 REVIEW OF INCIDENCES DURING THE MANUFACTURING PROCESS THE MANUFACTURING DOCUMENTATION OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, 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 644724016, EXP. 2024-09-14, WAS PREPARED WITH DONOR (B)(6). THE ENTRY TYPING OF THIS DONOR WAS REVIEWED AND NO DEVIATIONS WERE FOUND. THE DONORS (B)(6) WERE INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-S AND POSITIVE REACTIONS BETWEEN 2+ AND 3+ WERE OBTAINED. DONOR (B)(6) WAS ALSO TYPED USING MDMULTICARD BASIC EXTENDED PHENOTYPE AND A CLEAR POSITIVE S RESULT WAS OBTAINED. DONOR (B)(6) IS A NEW DONOR; ITS FIRST AND ONLY USE HAS BEEN IN THE MANUFACTURING OF CELL 3 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14. BESIDES THE CURRENT COMPLAINT, THERE IS NO OTHER COMPLAINT REGISTERED AGAINST FOR UNEXPECTED NEGATIVE ANTI-S ANTIBODY SCREENING RESULTS WITH SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14. HOWEVER, A PREVIOUS COMPLAINT CASE INVOLVING CELL 3 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14 WAS REGISTERED FOR A MISSED ANTI-FYA AND THIS CASE WAS REPORTED TO FDA ON 16 OCTOBER 2024 UNDER MANUFACTURER REPORT REFERENCE 3002806769-2024-00008. INTERNAL STABILITY RECORDS OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, WERE REVIEWED AND THE EXPECTED RESULTS WERE OBTAINED AT ALL TIME POINTS. CELL 3 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, GAVE STRONG REACTIONS (3+) WHEN TESTED WITH ANTI-S, REF. 213546, LOT 652722011B, EXP. 2025-02-28. CONCLUSIONS THE MANUFACTURING DOCUMENTATION OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, 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. THE CELL 3 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, IS AND REMAINS CLEARLY S-POSITIVE THROUGHOUT STABILITY, WHICH SUPPORTS ABSENCE OF MALFUNCTION. AS A CONCLUSION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS IS SAMPLE RELATED, POINTING TO A LOW-TITER ANTI-S IN THE PATIENT PLASMA THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS LOW ANTI-S 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 644724016, EXP. 2024-09-14. HOWEVER, AS PREVIOUSLY REPORTED ON 16 OCTOBER 2024 IN MANUFACTURER REPORT 3002806769-2024-00008, 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.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS ON ERYTRA EFLEXIS FOR ONE PATIENT, OBTAINED ON (B)(6) 2024 (SAMPLE ID (B)(6) WITH CELL 3 (E-; S+S-, DONOR (B)(6) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14. 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 644724016, EXP. 2024-09-14, USING DG GEL 8 ANTI-IGG CARDS LOT 24009.01, EXP. 2024-12-31. CELL 1 (E-; S-) AND CELL 3 (E-; S+S-, DONOR (B)(6) WERE INTERPRETED AS NEGATIVE. A 2+ REACTION WAS OBTAINED WITH CELL 2 (E+; S-). ANTIBODY IDENTIFICATION TESTING WAS PERFORMED ON THE SAMPLE ON THE SAME DAY AND ON THE SAME INSTRUMENT. SAMPLE ID "(B)(6)" WAS TESTED WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024017, EXP. 2024-09-28, USING DG GEL 8 ANTI-IGG CARDS LOT 24009.01, EXP. 2024-12-31. NEGATIVE REACTIONS WERE OBTAINED WITH HOMOZYGOUS S+ CELL 1 (S+S-, (B)(6) AND CELL 7 (S+S-, DONOR (B)(6), AS WELL AS WITH HETEROZYGOUS S+ CELL 5 (S+S+, (B)(6) AND CELL 11 (S+S+, DONOR (B)(6). POSITIVE REACTIONS (1+ AND 2+, RESPECTIVELY) WERE OBTAINED WITH BOTH E+ CELLS, CELL 4 (E+,S-) AND CELL 10 (E+,S-). THE AUTOCONTROL GAVE A "?" RESULT WHICH WAS MODIFIED TO A NEGATIVE RESULT BY THE OPERATOR. THE CUSTOMER STATED THAT AN ANTI-E AND ANTI-S WERE IDENTIFIED ON THE SAMPLE (ID "(B)(6). THE ANTI-S WAS IDENTIFIED BY POSITIVE REACTIONS (1+) OBTAINED WITH THREE HOMOZYGOUS S+ CELLS OF ORTHO PANEL 3 (0.8%), LOT VRB327, EXP. 2024-10-01. NO RAW IMAGE FILES OR LOG FILES ARE AVAILABLE FOR THIS SAMPLE. THE SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039979 SEARCH-CYTE TCS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY DETECTION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 644724016 07640137340384

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female