BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATA-CYTE PLUS 0.8%

    MDR report key: 24411362 · Received February 23, 2026

    Report

    Report Number
    3002806769-2026-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 31, 2026
    Report Date
    February 20, 2026
    Manufacturer
    MEDION GRIFOLS DIAGNOSTICS AG,
    Product Code
    QHT
    UDI-DI
    07640137340285
    PMA / PMN Number
    BL103898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DOCUMENTATION OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14, 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 2 (K+), CELL 5 (FYA+), CELL 7 (FYA+), CELL 8 (K+) AND CELL 9 (FYA+) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14, WERE PREPARED WITH DONORS (B)(6), RESPECTIVELY. THE ENTRY TYPING OF THESE DONORS WAS REVIEWED AND NO DEVIATIONS WERE FOUND. DONORS (B)(6), BOTH K+, WERE INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-K. IN EACH CASE, POSITIVE REACTIONS OF AT LEAST 3+ WERE OBSERVED. SIMILARLY, THE FYA+ DONORS (B)(6) WERE INDEPENDENTLY TYPED BY TWO LABORATORY TECHNICIANS WITH TWO DIFFERENT LOTS OF POLYCLONAL ANTI-FYA, AND POSITIVE REACTIONS OF AT LEAST 3+ WERE OBTAINED. THE HISTORY OF DONORS (B)(6) WAS ALSO REVIEWED. FOR DONOR (B)(6), TWELVE BLOOD UNITS RECEIVED WITHIN THE LAST FIVE YEARS WERE USED IN THE MANUFACTURING OF FOURTY FINISHED PRODUCTS ACROSS TWELVE MANUFACTURING CAMPAIGNS. IN ADDITION TO THE CURRENT REPORTED EVENT, ONE PREVIOUS COMPLAINT WAS REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG REGARDING A CELL MANUFACTURED WITH THIS DONOR. THAT COMPLAINT PERTAINED TO AN UNEXPECTED NEGATIVE RESULT (ANTI-C) OBTAINED WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024001, EXP. 2024-02-17, DURING CORRELATION TESTING VERSUS THE SOLID PHASE METHOD. NEVERTHELESS, THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE WAS SAMPLE RELATED, SPECIFICALLY A LOW-TITER ANTI-C AT THE DETECTION LIMIT OF THE GRIFOLS COLUMN AGGLUTINATION TECHNIQUE (CAT) SYSTEM. DONOR (B)(6) WAS USED IN THE MANUFACTURING OF CELL 5 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14, AS WELL AS IN FOURTEEN ADDITIONAL FINISHED PRODUCTS AMONG FOUR DIFFERENT MANUFACTURING CAMPAIGNS. BESIDES THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG AGAINST A CELL MANUFACTURED WITH DONOR (B)(6). FOR DONOR (B)(6), THREE BLOOD UNITS HAVE BEEN USED IN THE MANUFACTURING OF EIGHTEEN FINISHED PRODUCTS AMONG THREE MANUFACTURING CAMPAIGNS. APART FROM THE CURRENT REPORTED EVENT, NO SIMILAR COMPLAINTS HAVE BEEN REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG FOR CELLS MANUFACTURED WITH DONOR (B)(6). DONOR (B)(6) WAS USED IN THE MANUFACTURING OF CELL 8 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14, AS WELL AS IN ELEVEN OTHER FINISHED PRODUCTS ACROSS TWO DIFFERENT MANUFACTURING CAMPAIGNS. OTHER THAN THE CURRENT REPORTED EVENT, THERE HAS BEEN NO OTHER COMPLAINT REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG AGAINST A CELL MANUFACTURED WITH DONOR (B)(6). DONOR (B)(6) IS A NEW DONOR; ITS FIRST AND ONLY USE HAS BEEN IN THE MANUFACTURING OF CELL 9 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14. ASIDE FROM THE CURRENT REPORTED EVENT, NO OTHER COMPLAINTS HAVE BEEN REGISTERED BY MEDION GRIFOLS DIAGNOSTICS AG FOR CELLS MANUFACTURED WITH DONOR (B)(6). INTERNAL STABILITY RECORDS OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14, WERE REVIEWED. THE EXPECTED RESULTS WERE OBTAINED AT ALL TESTED TIME POINTS. TITRATION OF A SINGLE SOURCE POLYCLONAL ANTI-K WITH SELECTED K+ RRBC, INCLUDING THE CLAIMED CELL 2 AND CELL 8, AS WELL AS K+ RRBC FROM SEARCH-CYTE TCS 3%, REF. 213631, LOT 644026001, EXP. 2026-02-14, AND FROM ALTERNATIVE MANUFACTURER WHICH GAVE REACTIVITY WHEN TESTED AT CUSTOMER SITE USING PEG ENHANCER, WAS DONE IN MANUAL METHOD IN OUR QUALITY CONTROL LABORATORY AT MEDION GRIFOLS DIAGNOSTICS AG. THE SEVEN HETEROZYGOUS K+ RRBC TESTED GAVE A TITER BETWEEN 1:128 (INCLUDING CLAIMED CELL 2) AND 1:256 (INCLUDING CLAIMED CELL 8). THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY BETWEEN THE CLAIMED CELL 2 AND CELL 8 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14, AND THE OTHER RRBC TESTED AT CUSTOMER SITE WHICH GAVE REACTIVITY (WK TO 1+) WITH PEG ENHANCER. THESE RESULTS DO NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL K ANTIGEN EXPRESSION OF THE CLAIMED CELL 2 AND CELL 8 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14. TITRATION OF ANTI-FYA WITH SELECTED FYA+ RRBC, INCLUDING THE CLAIMED CELL 5, CELL 7 AND CELL 9 AS WELL AS FYA+ RRBC FROM SEARCH-CYTE TCS 3%, REF. 213631, LOT 644026001, EXP. 2026-02-14, AND FROM ALTERNATIVE MANUFACTURER WHICH GAVE REACTIVITY WHEN TESTED AT CUSTOMER SITE USING PEG ENHANCER, WAS DONE IN MANUAL METHOD IN OUR QUALITY CONTROL LABORATORY AT MEDION GRIFOLS DIAGNOSTICS AG. THE TWO HETEROZYGOUS FYA+ RRBC TESTED GAVE A TITER BETWEEN 1:16 (CELL 12 OF ALTERNATIVE MANUFACTURER WHICH GAVE A WK REACTIVITY WITH PEG) AND 1:32 (CLAIMED CELL 7). THE SIX HOMOZYGOUS FYA+ RRBC SHOWED A TITER BETWEEN 1:32 (INCLUDING CLAIMED CELL 5 AND CELL 9) AND 1:64. THESE RESULTS DEMONSTRATE COMPARABLE REACTIVITY AND DO NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL FYA ANTIGEN EXPRESSION OF THE CLAIMED CELL 5, CELL 7 AND CELL 9 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14. BASED ON THE ELEMENTS ABOVE AND ALSO CONSIDERING THAT THE ANTI-K AND ANTI-FYA IN THE PATIENT SAMPLE DID REACT WHEN TESTED IN TUBE METHOD WITH PEG ENHANCER, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS WITH K+ AND FYA+ CELLS (WHICH ARE E-) FROM DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14, IS SAMPLE RELATED, POINTING TO LOW-TITER ANTI-K AND ANTI-FYA ANTIBODIES IN THE PATIENT PLASMA WITH K AND FYA SPECIFICITY THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THESE LOW ANTI-K AND ANTI-FYA LEVELS 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 THE TWO HOMOZYGOUS FYA+ RRBC (WHICH WERE E- AND K-) FROM AN ALTERNATIVE MANUFACTURER, WHICH WERE TESTED IN TUBE METHOD USING PEG ENHANCER, DID NOT REACT EITHER (BOTH IN IS AND AHG). NO SINGLE METHOD IS ABLE TO DETECT ALL IRREGULAR ANTIBODIES. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCT DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14. CONSEQUENTLY, THIS CASE IS NON-CONFIRMED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION RESULTS FOR ANTI-K AND ANTI-FYA FOR ONE PATIENT, OBTAINED WITH CELL 2 (E-; K+K+; FYA-, DONOR (B)(6)), CELL 5 (E-; K-; FYA+B-, DONOR (B)(6)), CELL 7 (E-; K-; FYA+B+, DONOR (B)(6)), CELL 8 (E-; K+K+; FYA-, DONOR (B)(6)) AND CELL 9 (E-; K-; FYA+B-, DONOR (B)(6)) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14 (UDI: (B)(4)). IN ADDITION, THE CUSTOMER IDENTIFIED AN ANTI-E WHICH DEMONSTRATED IN GEL TECHNIQUE (AS WELL AS AN ANTI-I REACTING IN COLD ANTIBODY SCREENING). THE PATIENT IS A 67-YEAR-OLD MALE DIAGNOSED WITH ANEMIA, WITH NO PREVIOUS ANTIBODY HISTORY NOR RELEVANT MEDICATIONS. REGARDING TRANSFUSION HISTORY, THE PATIENT RECEIVED 4 UNITS OF PRBCS ON (B)(6) 2025 (2 UNITS WERE FYA+). ACCORDING TO THE INFORMATION AND DATA PROVIDED: 1. SAMPLE (B)(6) (PRE-TRANSFUSION): ON (B)(6) 2026: THE SAMPLE (B)(6) WAS TESTED FOR ANTIBODY SCREENING ON EFL2030 AT 14H01 USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644726011, EXP. 2026-02-14, ON DG GEL 8 ANTI-IGG CARDS, LOT 25604.1, EXP. 2026-03-31, AND CELL 2 (E+E-; K+K+; FYA+B-) WAS INTERPRETED AS 1+. THE TWO OTHER SCREENING CELLS WERE NEGATIVE. BASED ON THESE RESULTS, FURTHER INVESTIGATION WAS NEEDED AS ANTI-E, ANTI-K AND ANTI-FYA COULD NOT BE EXCLUDED. ACCORDINGLY, THE CUSTOMER PERFORMED ADDITIONAL TESTING. ANTIBODY IDENTIFICATION OF THE SAMPLE WAS THEN PROCESSED ON EFL2030 AT 14H52 USING DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14, ON DG GEL 8 ANTI-IGG CARD, LOT 25604.1, EXP. 2026-03-31, AND POSITIVE 1+ REACTIONS WERE OBTAINED FOR CELL 4 (E+E+; K-; FYA+B+), CELL 10 (E+E-; K-; FYA+B-) AND CELL 11 (E+E-; K-; FYA-). THE OTHER PANEL CELLS, INCLUDING THE CELL 2 (E-; K+K+; FYA-, DONOR (B)(6)), CELL 5 (E-; K-; FYA+B-, DONOR (B)(6)), CELL 7 (E-; K-; FYA+B+, DONOR (B)(6)), CELL 8 (E-; K+K+; FYA-, DONOR (B)(6)) AND CELL 9 (E-; K-; FYA+B-, DONOR (B)(6)) WERE NEGATIVE, AND THE AUTOCONTROL WAS INTERPRETED AS 2+. THESE RESULTS WERE MATCHING AN ANTI-E. ADDITIONAL TESTING IN TUBE METHOD WITH PEG ENHANCER WAS PERFORMED AND ANTI-K AND ANTI-FYA WITH 1+ TO 2+ REACTIVITY WERE IDENTIFIED. 1 DROP OF RRBC, 2 SERUM/PLASMA DROPS AND 2 DROPS OF ENHANCER WERE USED FOR THE TECHNIQUE, WITH A 15 MIN INCUBATION AT 37°C. THE FOLLOWING TESTS WERE CONDUCTED: WITH SEARCH-CYTE TCS 3%, REF. 213631, LOT 644026001, EXP. 2026-02-14, CELL 3 (E-; K+K+; FYA+B-) WAS INTERPRETED AS 1+ IN THE AHG METHOD, WHILE CELL 1 (E-; K-; FYA-) AND CELL 3 (E+E-; K-; FYA-) WERE NEGATIVE. ALL CELLS REACTED NEGATIVE IN IMMEDIATE SPIN (IS) METHOD. WITH SELECTED REAGENT RED BLOOD CELLS (RRBC) FROM AN ALTERNATIVE MANUFACTURER, IN AHG METHOD: O CELL 1 (E+E+; K-; FYA+B-) GAVE A 1+ REACTION. O CELL 4 (E-; K-; FYA-) WAS NEGATIVE. O CELL 7 (E-; K+K+; FYA-) GAVE A WEAK REACTION. O CELL 8 (E-; K-; FYA+B-) GAVE A 2+ REACTION. O CELL 11 (E+E+; K-; FYA+B-) GAVE A WEAK REACTION. O CELL 12 (E-; K-; FYA+BW) GAVE A WEAK REACTION. O CELL 14 (E-; K+K+; FYA-) GAVE A 1+ REACTION. O CELL 16 (E-; K-; FYA-) WAS NEGATIVE. ALL THE SELECTED RRBC TESTED NEGATIVE IN IS. THE AUTOCONTROL WAS TESTED IN PARALLEL AND REACTED NEGATIVE IN BOTH PHASES (IS, AHG). AS PER DATA SHEET PROVIDED BY THE CUSTOMER, ANTI-N AND ANTI-S WERE RULED OUT. WITH OTHER SELECTED RRBC FROM ALTERNATIVE MANUFACTURER, IN AHG METHOD: O CELL 5 (E-; K+K+; FYA-) GAVE A WEAK REACTION. O CELL 7 (E-; K+K+; FYA-) GAVE A 1+ REACTION. O CELL 11 (E-; K-; FYA-) WAS NEGATIVE. ALL THE SELECTED RRBC TESTED NEGATIVE IN IS. A DAT ASSAY WAS RUN ON THE SAMPLE AT 14H31 ON EFL2030 USING DG GEL 8 ANTI-IGG CARD, LOT 25604.1, EXP. 2026-03-31, AND A POSITIVE 3+ REACTION WAS OBTAINED. ACCORDING TO THE DOCUMENTATION PROVIDED, THE PATIENT WAS INDICATED AS BEING TYPED AS C-; E-; C+; K- AND FYA-. THE CUSTOMER REPORTED THAT THE ANTI-E WAS DEMONSTRATING IN GEL TECHNIQUE, HOWEVER NEGATIVE REACTIONS WERE OBTAINED FOR ANTI-K AND ANTI-FYA. THE ANTI-K AND ANTI-FYA WERE IDENTIFIED AND ALL OTHER CLINICALLY SIGNIFICANT ALLOANTIBODIES WERE RULED OUT WITH PEG ENHANCER, BEFORE THE PATIENT RECEIVED A TRANSFUSION (2 UNITS OF E- PRBCS) ON (B)(6) 2026. ON (B)(6) 2026: THIS SAMPLE COLLECTED BEFORE THE TRANSFUSION WAS TESTED ON EFL2030 BETWEEN 12H01 AND 13H25 WITH SELECTED 0.8% RRBC ON DG GEL 8 ANTI-IGG CARD, LOT 25608.1, EXP. 2026-04-30, OBTAINING THE FOLLOWING RESULTS: DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617026002, EXP. 2026-02-28. O CELL 1 (E-; K-; FYA-) REACTED NEGATIVE. O CELL 2 (E-; K+K+; FYA-) GAVE A NEGATIVE REACTION. O CELL 9 (E+E-; K-; FYA-) GAVE A 1+ REACTION. DATA-CYTE EXTEND 0.8%, REF. 213684, LOT 616026001, EXP. 2026-02-14. O CELL 4 (E+E+; K-; FYA-) GAVE A 1+ REACTION. SELECTED FYA+ (E-; K-) RRBC FROM ANOTHER ALTERNATIVE MANUFACTURER WERE TESTED IN TUBE METHOD USING PEG ENHANCER AND THE FOLLOWING RESULTS WERE OBTAINED BOTH IN AHG AND IS METHOD: CELL 4 (E-; K-; FYA+B-) REACTED NEGATIVE. CELL 12 (E-; K-; FYA+B-) GAVE A NEGATIVE REACTION. THE FYA+ RRBC FROM THIS OTHER ALTERNATIVE MANUFACTURER DID NOT REACT WHEN TESTED IN TUBE METHOD WITH PEG ENHANCER. 2. SAMPLE (B)(6) (POST-TRANSFUSION): ON (B)(6) 2026: THE SAMPLE (B)(6) COLLECTED AFTER THE TRANSFUSION OF 2 E- UNITS OF PRBCS FOLLOWING THE IDENTIFICATION OF ANTI-I, ANTI-E, ANTI-K AND ANTI-FYA ON (B)(6) 2026, WAS TESTED FOR DAT ASSAY AT 10H20 ON EFL2030 USING DG GEL 8 ANTI-IGG CARD, LOT 25608.1, EXP. 2026-04-30, AND THE DAT WAS 1+ POSITIVE. THE SAMPLE WAS THEN PROCESSED FOR ANTIBODY IDENTIFICATION ON EFL2030 AT 11H08 USING DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617026002, EXP. 2026-02-28, ON DG GEL 8 ANTI-IGG CARD, LOT 25608.1, EXP. 2026-04-30, AND POSITIVE 1+ REACTIONS WERE OBTAINED FOR CELL 4 (E+E+; K-; FYA+ BW), CELL 9 (E+E-; K-; FYA-) AND CELL 10 (E+E-; K-; FYA+B+). THE OTHER PANEL CELLS, INCLUDING CELL 2 (E-; K+K+; FYA-), CELL 3 (E-; K-; FYA+B-), CELL 8 (E-; K+K+; FYA+B+) AND CELL 11 (E-; K-; FYA+B-) WERE NEGATIVE. THESE RESULTS ARE MATCHING AN ANTI-E AND ARE SIMILAR TO THE ONES OBTAINED ON (B)(6) 2026 WITH THE SAMPLE "N3970538713" BEFORE THE TRANSFUSION, WITH THE CLAIMED DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14. ANTIBODY SCREENING WAS CONDUCTED ON EFL2030 AT 12H07 USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644726001, EXP. 2026-02-14, ON DG GEL 8 ANTI-IGG CARDS, LOT 25608.1, EXP. 2026-04-30, AND CELL 2 (E+E-; K+K+; FYA+B-) WAS INTERPRETED AS 1+. THE TWO OTHER SCREENING CELLS WERE NEGATIVE. THESE RESULTS ARE SIMILAR TO THE ONES OBTAINED ON (B)(6) 2026 WITH THE SAMPLE (B)(6) BEFORE THE TRANSFUSION. THE CUSTOMER PERFORMED ADDITIONAL TESTING ON THE SAMPLE IN MANUAL GEL METHOD USING A 30 MINUTE INCUBATION (NO INFORMATION ON LOT OF DG GEL 8 ANTI-IGG CARD USED) USING SELECTED RRBC: SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644726001, EXP. 2026-02-14. O CELL 1 (E-; K-; FYA-) REACTED NEGATIVE. O CELL 2 (E+E-; K+K+; FYA+B-) GAVE A 1+ REACTION. O CELL 3 (E-; K-; FYA-) REACTED NEGATIVE. THESE RESULTS ARE SIMILAR TO THE REACTIONS OBTAINED WITH THE REAGENT WHEN TESTED WITH 15 MINUTES INCUBATION METHOD (BOTH SAMPLES BEFORE AND AFTER TRANSFUSION). - DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617026002, EXP. 2026-02-28. O CELL 1 (E-; K-; FYA-) REACTED NEGATIVE. O CELL 2 (E-; K+K+; FYA-) WAS NEGATIVE. O CELL 6 (E-; K-; FYA-) REACTED NEGATIVE. O CELL 9 (E+E-; K-; FYA-) GAVE A 2+ REACTION. - CLAIMED DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610026001, EXP. 2026-02-14. O CELL 2 (E-; K+K+; FYA-) WAS NEGATIVE. O CELL 5 (E-; K-; FYA+B-) GAVE A NEGATIVE REACTION. O CELL 7 (E-; K-; FYA+B+) WAS NEGATIVE. O CELL 8 (E-; K+K+; FYA-) GAVE A NEGATIVE REACTION. O CELL 9 (E-; K-; FYA+B-) WAS NEGATIVE. O CELL 11 (E+E-; K-; FYA-) GAVE A 2+ REACTION. THESE RESULTS WITH SELECTED RRBC ARE SIMILAR TO THE REACTIONS OBTAINED WITH THE REAGENT WHEN TESTED WITH 15 MINUTES INCUBATION METHOD ON THE SAMPLE COLLECTED BEFORE TRANSFUSION (ANTI-K AND ANTI-FYA NOT REACTING). DATA-CYTE EXTEND 0.8%, REF. 213684, LOT 616026001, EXP. 2026-02-14 O CELL 4 (E+E+; K-; FYA-) GAVE A 1+ REACTION. IT SHALL BE NOTED THAT COMPARABLE REACTIVITY WAS OBTAINED BETWEEN THE RESULTS OBTAINED WITH THE PRE-TRANSFUSION SAMPLE (B)(6) AND THE POST-TRANSFUSION SAMPLE (B)(6). UPON REQUEST, THE CUSTOMER STATED THAT AFTER THE TRANSFUSION, THE PATIENT HAD THE FOLLOWING SYMPTOMS: CHEST PAINT, HEADACHE, ANXIETY AND INCREASED BLOOD PRESSURE FROM 142/85 TO 166/87. IT WAS INDICATED THAT THE PATIENT IS OKAY, AND THE PATHOLOGIST ADVISED SYMPTOMS WERE UNRELATED TO THE TRANSFUSION. AS PER L2 INVESTIGATION, REVIEW OF THE INSTRUMENT LOGS SHOWED NO ERRORS DURING THE TIME OF TESTING OF THE PATIENT SAMPLES, WHICH RULES OUT THE INSTRUMENT AS A POSSIBLE CAUSE OF THE UNEXPECTED NEGATIVE REACTIONS. A REVIEW OF THE PRE-PROCESSING INTEGRITY CHECK IMAGES SHOWED THAT ALL THE USED CARDS WERE ACCEPTABLE, WITH NO BUFFER SPLASHING OR DISPLACED GEL NOTED FOR ANY OF THE CARDS USED IN THE TESTING OF THE SAMPLES, WHICH RULES OUT THE GEL CARDS AS A POSSIBLE CAUSE OF THE UNEXPECTED REACTIONS. REVIEW OF THE POST-PROCESSING FINAL IMAGE READS SHOWED AGGLUTINATION PATTERNS THAT ARE VISUALLY CONSISTENT WITH THE INSTRUMENT ALGORITHM ASSIGNMENTS. THE SAMPLE INCUBATION TIMES WERE 15 MINUTES, AND AN APPROPRIATE AMOUNT OF PLASMA WAS DISPENSED INTO THE WELLS. THE CUSTOMER ADVISED THEY DO NOT HAVE ENOUGH SAMPLE LEFT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478028 DATA-CYTE PLUS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 610026001 07640137340285

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male