BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE PLUS 0.8%

    MDR report key: 23081923 · Received September 18, 2025

    Report

    Report Number
    3002806769-2025-00010
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 18, 2025
    Manufacturer
    MEDION GRIFOLS DIAGNOSTICS AG,
    Product Code
    QHT
    UDI-DI
    07640137340377
    PMA / PMN Number
    BL103898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DOCUMENTATION OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, 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. AT RELEASE TESTING, THE CELL 1 (C+C-) FROM THE SCREENING PANEL WAS INTERPRETED AS 4+ WHEN TESTED WITH DG GEL 8 RH PHENO CARD, REF. 210228, LOT 24011.01, EXP. 2026-02-28. CELL 1 OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, EXP. 2025-08-02, WAS PREPARED WITH DONOR (B)(6). THE ENTRY TYPING OF THIS DONOR WAS REVIEWED AND NO DEVIATIONS WERE FOUND. DONOR (B)(6) WAS INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF ANTI-C REAGENTS AND STRONG POSITIVE REACTIONS WERE OBTAINED. SIX BLOOD UNITS FROM DONOR (B)(6) HAVE BEEN USED IN THE MANUFACTURING OF TEN FINISHED PRODUCTS AMONG SIX DIFFERENT MANUFACTURING, INCLUDING AS THE CLAIMED CELL 1 OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, EXP. 2025-08-02. BESIDES THE CURRENT REPORTED EVENT, NO OTHER SIMILAR COMPLAINT HAS BEEN REGISTERED TO DATE BY MEDION GRIFOLS DIAGNOSTICS AG FOR SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, EXP. 2025-08-02, NOR ANY OTHER PRODUCT MANUFACTURED WITH DONOR (B)(6). INTERNAL STABILITY RECORDS OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, EXP. 2025-08-02, WERE REVIEWED AND THE EXPECTED RESULTS WERE OBTAINED AT ALL TIME POINTS. BASED ON ALL THE ELEMENTS, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS WITH CELL 1 (DONOR (B)(6)) OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, EXP. 2025-08-02, IS SAMPLE RELATED, POINTING TO A LOW-TITER ANTI-C IN THE PATIENT PLASMA WITH C SPECIFICITY 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 RESULTS OBSERVED BY THE CUSTOMER. IT SHALL BE NOTED THAT WHILE UNEXPECTED NEGATIVE RESULTS WERE OBTAINED ON (B)(6) 2025 WHEN TESTING SAMPLE "(B)(6)" WITH THE CLAIMED SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, EXP. 2025-08-02, NEGATIVE RESULTS WERE ALSO OBTAINED WHEN SAMPLE "(B)(6)" WAS TESTED ON (B)(6) 2025 WITH DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617025014, EXP. 2025-08-16, AND WHEN THE PATIENT WAS TESTED ON (B)(6) 2025 WITH UNTREATED RRBCS FROM ALTERNATIVE MANUFACTURER. THE ANTI-C WAS IDENTIFIED BASED ON TESTING FROM (B)(6) 2025 WITH FICIN-TREATED RRBCS FROM ALTERNATIVE MANUFACTURER (NO RESULTS WERE PROVIDED). NEVERTHELESS, WHEN THE PATIENT WAS TESTED ON (B)(6) 2025 WITH THE SAME PANEL, THE FICIN-TREATED RRBCS GAVE MIXED FIELD RESULTS (BUT NEGATIVE REACTIONS WERE OBTAINED WITH UNTREATED RRBCS AS INDICATED ABOVE). BASED ON THIS, IT HIGHLIGHTS THAT THE DETECTION OF THIS ANTI-C IS DEPENDENT ON THE USAGE OF ENHANCEMENT MEDIA, WHICH FURTHER SUPPORTS THE PRESENCE OF A LOW-TITER ANTI-C IN THE PATIENT PLASMA. NO SINGLE METHOD IS ABLE TO DETECT ALL IRREGULAR ANTIBODIES. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCT SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, EXP. 2025-08-02. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS ON ERYTRA FOR ONE PATIENT, OBTAINED WITH CELL 1 (C+C-, DONOR (B)(6)) OF SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, EXP. 2025-08-02, (UDI: (B)(4)). AS PER CUSTOMER, AN ANTI-C WAS SUBSEQUENTLY IDENTIFIED USING FICIN-TREATED RRBCS FROM ALTERNATIVE MANUFACTURER. ACCORDING TO THE INFORMATION AND DATA PROVIDED: SAMPLES "(B)(6)" (UNKNOWN COLLECTION DATE) AND "(B)(6)" (SECOND DRAW, UNKNOWN COLLECTION DATE) ORIGINATE FROM A PATIENT DIAGNOSED WITH MYELOFIBROSIS AND WHO REQUIRES WEEKLY TRANSFUSIONS IN THE OUTPATIENT CLINIC. IT WAS INDICATED THAT THE PATIENT WAS TRANSFUSED WITH 10 BLOOD UNITS BETWEEN (B)(6) 2025, SO THEY WERE NOT ABLE TO PHENOTYPE THE PATIENT. ON (B)(6) 2025, SAMPLE "(B)(6)" WAS TESTED FOR ANTIBODY SCREENING ON ERYTRA INSTRUMENT ERY1684 (SN (B)(6)) AT 15H29 USING SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643525013, EXP. 2025-08-02, ON DG GEL 8 ANTI-IGG CARD, LOT 25014.1, EXP. 2026-01-31, AND BOTH SCREENING CELL 1 (C+C-, DONOR (B)(6)) AND CELL 2 (C-) REACTED NEGATIVE. THE PATIENT WAS TRANSFUSED WITH TWO BLOOD UNITS, ONE OF WHICH WAS CONFIRMED TO BE C+. THE SAMPLE "(B)(6)" WAS TESTED ON (B)(6) 2025 AT 22H48 ON ERY1684 FOR ANTIBODY IDENTIFICATION ON THE SAME INSTRUMENT USING DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617025014, EXP. 2025-08-16, ON DG GEL 8 ANTI-IGG CARDS, LOT 25016.1, EXP. 2026-02-28, AND ALL PANEL CELLS (AS WELL AS THE AUTOCONTROL) WERE INTERPRETED AS NEGATIVE BY THE INSTRUMENT, INCLUDING CELL 3 (C+C+), CELL 7 (C+C-), CELL 8 (C+C-) AND CELL 9 (C+WC+). THE CUSTOMER STATED THAT AN ANTI-C WAS IDENTIFIED USING FICIN-TREATED RRBCS FROM ALTERNATIVE MANUFACTURER; NO RESULTS WERE PROVIDED. THE DAT RESULT OF BOTH SAMPLES WAS NEGATIVE (NO RESULTS PROVIDED); THEREFORE, NO ELUATES WERE PERFORMED. AS PER INFORMATION PROVIDED, TWO BLOOD UNITS WERE TRANSFUSED TO THE PATIENT ON (B)(6) 2025. BOTH BLOOD UNITS WERE C NEGATIVE (FOLLOWING THE IDENTIFICATION OF THE ANTI-C ON (B)(6) 2025 USING FICIN-TREATED RRBCS FROM ALTERNATIVE MANUFACTURER). AS PER CUSTOMER, FURTHER TESTING ON A DIFFERENT DRAW/SAMPLE (UNKNOWN ID) USING UNTREATED AND FICIN-TREATED RRBCS FROM ALTERNATIVE MANUFACTURER, WAS PERFORMED ON (B)(6) 2025. WHILE ALL UNTREATED PANEL RRBC WERE NEGATIVE, THE FICIN-TREATED PANEL GAVE MIXED FIELD REACTIONS FOR ALL C+ RRBCS. NO RESULTS NOR DATA WERE PROVIDED. THE SAMPLE "(B)(6)" WAS TESTED FOR ANTIBODY IDENTIFICATION AT 15H48 ON ERY1684 USING DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617025014, EXP. 2025-08-16, ON DG GEL 8 ANTI-IGG CARDS, LOT 25016.1, EXP. 2026-02-28, AND ALL PANEL CELLS INCLUDING THE AUTOCONTROL, GAVE NON INTERPRETABLE "NRD" RESULTS DUE TO RBC EXCESS (THE SAMPLE PLASMA VOLUME WAS TOO LOW). AS PER L2 INVESTIGATION, NO RAW IMAGES WERE COLLECTED FOR SAMPLE "(B)(6)" TESTED ON (B)(6) 2025, THEREFORE UNABLE TO EVALUATE THE INTEGRITY OF CARDS. THE REVIEW OF THE LOG REVEALED NO ERRORS ON THE INSTRUMENT NOTED AT THE TIME OF TESTING ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705755 SEARCH-CYTE PLUS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 643525013 07640137340377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male