BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATA-CYTE PLUS P 0.8%

    MDR report key: 22699250 · Received August 4, 2025

    Report

    Report Number
    3002806769-2025-00006
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    June 9, 2025
    Report Date
    August 4, 2025
    Manufacturer
    MEDION GRIFOLS DIAGNOSTICS AG,
    Product Code
    QHT
    UDI-DI
    07640137342272
    PMA / PMN Number
    BL103898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    I. DOCUMENTARY INVESTIGATION THE MANUFACTURING DOCUMENTATION OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, 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, ANTIGEN TYPING WAS PERFORMED WITH COMMERCIAL ANTI-K REAGENT AND BOTH K+ CELL 2P AND CELL 8P WERE INTERPRETED AS 3+. CELL 2P AND CELL 8P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, WERE PREPARED WITH DONORS (B)(6), RESPECTIVELY. THE ENTRY TYPING OF DONORS (B)(6) WAS REVIEWED, AND NO DEVIATIONS WERE FOUND. ALL DONORS WERE INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-K. THE POSITIVE REACTIONS RANGED BETWEEN 3+ AND 4+. THE HISTORY OF DONORS (B)(6) WAS REVIEWED. TWO BLOOD UNITS FROM DONOR (B)(6) HAVE BEEN USED IN THE MANUFACTURING OF SEVEN FINISHED PRODUCTS IN TWO DIFFERENT MANUFACTURING CAMPAIGNS, INCLUDING CELL 2P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, AND CELL 2 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025011, EXP. 2025-07-05. DONOR (B)(6) IS A NEW DONOR; ITS FIRST AND ONLY USE HAS BEEN IN THE MANUFACTURING OF CELL 8P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, AS WELL AS IN FIVE OTHER FINISHED PRODUCTS FROM THE SAME MANUFACTURING CAMPAIGN, INCLUDING CELL 8 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025011, EXP. 2025-07-05. BESIDES THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG INVOLVING DONOR (B)(6). INTERNAL STABILITY RECORDS OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, WERE REVIEWED. THE EXPECTED RESULTS WERE OBTAINED AT ALL TESTED TIME POINTS. II. INVESTIGATIVE TESTING UPON COMPLAINT RECEPTION, ON (B)(6) 2025, INVESTIGATIVE TESTING CONSISTING IN IAT TESTING USING POLYCLONAL ANTI-K FROM HUMAN PLASMA WITH SELECTED RRBCS FROM DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05 (PAPAINIZED PANEL), AND DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025011, EXP. 2025-07-05 (NATIVE PANEL), INCLUDING BOTH K+ (HETEROZYGOUS) CELL 2/2P AND CELL 8/8P, AS WELL AS ONE NEGATIVE CONTROL (CELL 1/1P, K-), WAS DONE IN MANUAL METHOD IN OUR QUALITY CONTROL LABORATORY AT MEDION GRIFOLS DIAGNOSTICS AG. THE SELECTED RRBCS WERE TESTED EACH IN DG GEL 8 ANTI-IGG CARD, LOT 24033.01, EXP. 2025-07-31, AND IN DG GEL 8 NEUTRAL CARD, LOT 24017.01, EXP. 2025-07-31; EACH PANEL WAS TESTED ACCORDING TO THE IFU (NATIVE PANEL IN IGG CARDS, PAPAINIZED PANEL IN NEUTRAL CARDS) AS WELL AS WITH THE OTHER CARD FOR INVESTIGATION (NATIVE PANEL IN NEUTRAL CARDS, PAPAINIZED PANEL IN IGG CARDS). EACH TEST WAS PERFORMED BY PIPETTING 50 L 0.8% RRBCS AND 25 L POLYCLONAL ANTI-K (HUMAN PLASMA), FOLLOWED BY 15 MINUTES INCUBATION AT 37°C AND 9 MINUTES CENTRIFUGATION. THE NATIVE K+ CELL 2 AND CELL 8 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025011, EXP. 2025-07-05, WERE BOTH INTERPRETED AS 3+ WHEN TESTED IN DG GEL 8 ANTI-IGG CARD, AS PER IFU TECHNIQUE. THE CLAIMED PAPAINIZED K+ CELL 2P AND CELL 8P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, WERE BOTH INTERPRETED POSITIVE (2+) AS EXPECTED WHEN TESTED IN DG GEL 8 NEUTRAL CARD, AS PER IFU TECHNIQUE, MORE THAN THREE WEEKS AFTER EXPIRATION DATE. REGARDING THE TWO INVESTIGATIVE TESTS, WHEN THE PAPAINIZED PANEL CELLS WERE TESTED IN DG GEL 8 ANTI-IGG CARD, THE REACTIVITY WAS ENHANCED TO 3+ FOR BOTH K+ CELLS IN COMPARISON WITH THE IFU METHOD IN DG GEL 8 NEUTRAL CARD, WHERE POSITIVE 2+ REACTIONS WERE OBTAINED. ON THE OTHER HAND, WHEN NATIVE PANEL CELLS WERE TESTED IN DG GEL 8 NEUTRAL CARD, THE K+ CELLS WERE INTERPRETED AS +/- (CELL 2) AND 1+ (CELL 8), IN COMPARISON WITH THE IFU METHOD IN DG GEL 8 ANTI-IGG CARD, WHERE 3+ REACTIONS WERE OBSERVED. THIS INVESTIGATIVE TESTING DEMONSTRATES THE INFLUENCE/IMPORTANCE OF IGG IN THE REACTIVITY. THE NEGATIVE CONTROL CELL 1/1P REACTED NEGATIVE AS EXPECTED IN ALL TESTING. NEVERTHELESS, WITH THE POLYCLONAL ANTI-K FROM HUMAN PLASMA USED IN THE TESTING, THE REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CELL 2P AND CELL 8P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, ON DG GEL 8 NEUTRAL CARD, HAVE NOT BEEN REPRODUCED IN MEDION GRIFOLS DIAGNOSTICS AG. THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY AND DO NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL K ANTIGEN EXPRESSION OF THE CLAIMED CELL 2P AND CELL 8P OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05. BASED ON THE ELEMENTS ABOVE AND ALSO CONSIDERING THE KNOWN PRESENCE OF ANTI-K, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED EVENTS IS SAMPLE RELATED, POINTING TO THE INHERENT FEATURES OF THE ANTI-K PRESENT IN THE PLASMA OF THE TWO PATIENTS. AS INDICATED BY THE CUSTOMER, THE THIRD PATIENT SAMPLE TESTED GAVE THE EXPECTED REACTIVITY IN THE PAPAINIZED PANEL DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, CONSISTENT WITH ANTI-K. THE INVESTIGATIVE TESTING PERFORMED AT MEDION GRIFOLS DIAGNOSTICS AG WITH POLYCLONAL ANTI-K (HUMAN PLASMA) SHOWED THAT WHEN THE PAPAINIZED PANEL CELLS WERE TESTED IN DG GEL 8 ANTI-IGG CARD, THE REACTIVITY WAS ENHANCED TO 3+ IN COMPARISON WITH THE IFU METHOD IN DG GEL 8 NEUTRAL CARD, WHERE POSITIVE 2+ REACTIONS WERE OBTAINED. THE INFLUENCE/IMPORTANCE OF IGG IN THE REACTIVITY WAS FURTHER DEMONSTRATED WHEN NATIVE PANEL CELLS (DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025011, EXP. 2025-07-05) WERE TESTED IN DG GEL 8 NEUTRAL CARD, WHERE THE K+ CELLS WERE INTERPRETED BETWEEN +/- AND 1+, IN COMPARISON WITH THE IFU METHOD IN DG GEL 8 ANTI-IGG CARD, WHERE 3+ REACTIONS WERE OBSERVED. ACCORDING TO THIS, IT SUGGESTS THAT THE ANTI-K PRESENT IN THE PLASMA OF THE TWO PATIENTS WHICH DID NOT REACT WITH PAPAINIZED K+ CELLS IN NEUTRAL CARDS, IS DEPENDING ON THE PRESENCE OF IGG FOR DETECTION. AS PER LITERATURE, IGG ALLOANTI-K ARE MORE COMMON THAN IGM ALLOANTI-K (MARION E. REID, CHRISTINE LOMAS-FRANCIS AND MARTIN L. OLSSON, "THE BLOOD GROUP ANTIGEN FACTSBOOK", 3RD EDITION, 2012). MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON TWO ERYTRA INSTRUMENTS FOR ANTI-K, OBTAINED WITH BOTH K+ CELLS, CELL 2P (K+K+, DONOR (B)(6) AND CELL 8P (K+K+, DONOR (B)(6) OF DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05 (UDI: (B)(4). THIS OCCURRED WITH TWO PATIENT SAMPLES "(B)(6)" WITH KNOWN ANTI-K DURING VALIDATION OF DATA-CYTE PLUS P 0.8% (REF. 213688) BY COMPARATIVE TESTING WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025011, EXP. 2025-07-05. WHILE THE UNTREATED (NATIVE) PANEL CELLS SUCCESSFULLY DEMONSTRATED THE PRESENCE OF THE ANTI-K IN DG GEL 8 ANTI-IGG CARDS, THE ENZYME TREATED (PAPAINIZED) K+ PANEL CELLS 2P AND 8P DID NOT REACT IN DG GEL 8 NEUTRAL CARDS. HOWEVER, IT WAS INDICATED THAT A THIRD PATIENT SAMPLE WAS TESTED WITH THE CLAIMED DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, AND GAVE THE EXPECTED REACTIVITY, CONSISTENT WITH ANTI-K (NO DETAILS NOR RESULTS PROVIDED). ACCORDING TO THE INFORMATION PROVIDED: SAMPLE "(B)(6) WAS COLLECTED ON (B)(6) 2025 AND ORIGINATES FROM A 53-YEAR-OLD FEMALE PATIENT ADMITTED FOR PRE-LIVER TRANSPLANT EVALUATION. THE PATIENT IS CURRENTLY UNDER BENADRYL TREATMENT, WAS TRANSFUSED ON (B)(6) 2024 (2 RBC, 1 PLT) AND HAS A HISTORY OF ANTI-K. THE SAMPLE WAS TESTED ON (B)(6) 2025 AT 11H01 FOR ANTIBODY IDENTIFICATION ON ERYTRA INSTRUMENT ERY1320 (SN (B)(6), SOFTWARE VERSION 4.5.0, REAGENT PACK VERSION 2.3) WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025011, EXP. 2025-07-05, ON DG GEL 8 ANTI-IGG CARD, LOT 25007.1, EXP. 2025-12-31. CELL 2 (K+K+) AND CELL 8 (K+K+) WERE INTERPRETED AS 1+ AND 2+ BY THE INSTRUMENT, RESPECTIVELY, WHILE ALL THE OTHER CELLS REACTED NEGATIVE, INCLUDING THE AUTOCONTROL. THE SAMPLE WAS ALSO PROCESSED ON THE SAME INSTRUMENT AT 11H05 FOR ANTIBODY IDENTIFICATION WITH DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, ON DG GEL 8 NEUTRAL CARD, LOT 25005.1, EXP. 2025-12-31, AND ALL CELLS WERE INTERPRETED AS NEGATIVE, INCLUDING BOTH K+ CELL 2P AND CELL 8P. ON (B)(6) 2025, THE SAMPLE WAS PROCESSED AGAIN FOR ANTIBODY IDENTIFICATION AT 10H37 ON ERYTRA INSTRUMENT ERY1321 (SN (B)(6), SOFTWARE VERSION 4.5.0, REAGENT PACK VERSION 2.3) WITH DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, ON DG GEL 8 NEUTRAL CARD, LOT 25005.1, EXP. 2025-12-31, AND SIMILAR RESULTS WERE OBTAINED; ALL CELLS WERE INTERPRETED AS NEGATIVE, INCLUDING BOTH K+ CELL 2P AND CELL 8P. SAMPLE "(B)(6) WAS COLLECTED ON (B)(6) 2025 AND ORIGINATES FROM A 78-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH CALCULUS OF KIDNEY AND WITH NO RELEVANT MEDICATION. THE PATIENT WAS TRANSFUSED ON (B)(6) 2021 (1 RBC) AND HAS A HISTORY OF ANTI-K. THE SAMPLE WAS TESTED ON (B)(6) 2025 AT 13H30 FOR ANTIBODY IDENTIFICATION ON ERY1321 WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610025011, EXP. 2025-07-05, ON DG GEL 8 ANTI-IGG CARD, LOT 25007.1, EXP. 2025-12-31. CELL 2 (K+K+) WAS INTERPRETED AS 1+, CELL 7 (K-, WRA+) AND CELL 8 (K+K+) WERE BOTH INTERPRETED AS 2+ BY THE INSTRUMENT, WHILE ALL THE OTHER CELLS REACTED NEGATIVE, INCLUDING THE AUTOCONTROL. THE SAMPLE WAS ALSO PROCESSED ON THE SAME INSTRUMENT AT 13H36 FOR ANTIBODY IDENTIFICATION WITH DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, ON DG GEL 8 NEUTRAL CARD, LOT 25005.1, EXP. 2025-12-31, AND ALL CELLS WERE INTERPRETED AS NEGATIVE (INCLUDING BOTH K+ CELL 2P AND CELL 8P), EXCEPT THE CELL 7P (K-, WRA+) WHICH WAS INTERPRETED AS 3+ (INCREASED) BY THE INSTRUMENT. ON (B)(6) 2025, THE SAMPLE WAS PROCESSED AGAIN FOR ANTIBODY IDENTIFICATION AT 10H48 ON ERY1320 WITH DATA-CYTE PLUS P 0.8%, REF. 213688, LOT 614025011, EXP. 2025-07-05, ON DG GEL 8 NEUTRAL CARD, LOT 25005.1, EXP. 2025-12-31, AND SIMILAR RESULTS WERE OBTAINED; ALL CELLS WERE INTERPRETED AS NEGATIVE (INCLUDING BOTH K+ CELL 2P AND CELL 8P), EXCEPT FOR CELL 7P WHICH GAVE A 3+ REACTION (NOTE: THERE WAS AN INCIDENCE OF "VOLUME NOT DETECTED" FOR CELL 6P). NO ALTERNATIVE TESTING WAS PERFORMED. AS PER L2 INVESTIGATION, ONLY AN INVESTIGATION OF THE LOGS FOR ERY1320 (ERYTRA SN (B)(6) COULD BE CARRIED OUT AS THE LOGS FOR ERY1321 ARE NOT AVAILABLE. NO ERRORS WERE NOTED ON ERY1320 AT THE TIMEFRAME BOTH SAMPLES WERE TESTED. RAW IMAGES WERE NOT AVAILABLE FOR ERY1321. HOWEVER, RAW IMAGES FOR PAPAINIZED PANEL TESTING WERE AVAILABLE FOR INVESTIGATION. INTEGRITY CHECK IMAGES DEMONSTRATED NO GEL DISPLACEMENT OR BUFFER SPLASHING. REVIEW OF POST-PROCESSING IMAGES CONFIRMED THAT REACTIONS AGREED WITH THE GRADING ALGORITHM OF THE INSTRUMENT. HOWEVER, IT WAS OBSERVED THAT SEVERAL WELLS HAD BUBBLES IN THE UPPER INCUBATION CHAMBER (WELLS 2, 4, 7 AND 8 OF CARD (B)(4) WHICH COULD CAUSE PROZONE ISSUES DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585013 DATA-CYTE PLUS P 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 614025011 07640137342272

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female