BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE TCS 0.8%

    MDR report key: 20426312 · Received October 11, 2024

    Report

    Report Number
    3002806769-2024-00006
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 10, 2024
    Report Date
    October 11, 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

    THE INVESTIGATIVE TESTING PERFORMED IN THE QUALITY CONTROL LABORATORY OF MEDION GRIFOLS DIAGNOSTICS AG SHOWED A COMPARABLE TITER BETWEEN THE TESTED HOMOZYGOUS E+ RRBCS (INCLUDING CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, AND CELL 10 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 644724017, EXP. 2024-09-28) AND ALSO BETWEEN THE TESTED HETEROZYGOUS E+ RRBCS (INCLUDING CELL 4 OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 644724017, EXP. 2024-09-28), WHICH DOES NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL E ANTIGEN EXPRESSION OF THESE CELLS AND DOES NOT DEMONSTRATE ANY MALFUNCTION OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, AND DATA-CYTE PLUS 0.8%, REF. 213654, LOT 644724017, EXP. 2024-09-28. THUS, THE INVESTIGATIVE TESTING IS SUPPORTING THE HYPOTHESIS OF THE PRESENCE OF A LOW-TITER ANTI-E ANTIBODY IN THE PATIENT PLASMA THAT IS AT THE DETECTION LIMIT OF THE GEL SYSTEM. AS A CONCLUSION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS WITH CELL 2 (DONOR (B)(6)) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, AS WELL AS CELL 4 (DONOR (B)(6)) AND CELL 10 (DONOR (B)(6)) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 644724017, EXP. 2024-09-28, IS SAMPLE RELATED, POINTING TO A NEWLY-FORMING LOW-TITER ANTI-E IN THE PATIENT PLASMA WITH E SPECIFICITY THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS LOW ANTI-E 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. 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, AND DATA-CYTE PLUS 0.8%, REF. 213654, LOT 644724017, EXP. 2024-09-28.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING/IDENTIFICATION RESULTS FOR ONE PATIENT SAMPLE, OBTAINED WITH CELL 2 (E+E-) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14 (UDI: (B)(4)), AS WELL AS WITH CELL 4 (E+E+) AND CELL 10 (E+E-) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024017, EXP. 2024-09-28 (UDI: (B)(4)). ACCORDING TO THE INFORMATION IN THE WORK ORDER, TWO SAMPLES WERE COLLECTED ON 27 AUGUST (PRE-TRANSFUSION SAMPLE "(B)(6)") AND 10 SEPTEMBER 2024 (POST-TRANSFUSION SAMPLE "(B)(6)") AND ORIGINATE FROM A 31 YEARS OLD MALE PATIENT DIAGNOSED WITH COVID-19 AND WITHOUT ANY RELEVANT MEDICATION. THE PATIENT WAS TRANSFUSED ON (B)(6) 2024. ON (B)(6) 2024, THE PRE-TRANSFUSION SAMPLE "(B)(6)" WAS COLLECTED AND TESTED ON ERYTRA 1837 (SN (B)(6), SOFTWARE VERSION 4.3.3) AT 02:07:31 WITH SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724015, EXP. 2024-08-31, ON DG GEL 8 ANTI-IGG CARDS LOT *013.01 (EXP. 2025-03-31), AND ALL THREE SCREENING REAGENT RED BLOOD CELLS (RRBCS) WERE INTERPRETED AS NEGATIVE. TYPING RESULTS PERFORMED ON THE SAME INSTRUMENT WERE ALSO PROVIDED; THE PATIENT SAMPLE WAS TYPED AS A POS. AT THAT TIME, THE PATIENT WAS INDICATED AS NEVER HAVING BEEN PREVIOUSLY TRANSFUSED. THIS PRE-TRANSFUSION SAMPLE HAS BEEN DISCARDED AND NO ADDITIONAL TESTING WAS PERFORMED. NO RAW IMAGES OF THE TESTING WERE AVAILABLE. FOLLOWING THE NEGATIVE SCREENING TESTING, THE PATIENT WAS THEN TRANSFUSED WITH ONE A POS BLOOD UNIT "(B)(6)" WHICH WAS LATER CONFIRMED TO BE E+ (TESTED ON (B)(6) 2024 AT 17:32:13 ON ERYTRA 1837 WITH DG GEL 8 ANTI-E CARD LOT *001.01 (EXP. 2026-04-30); A 4+ REACTION WAS OBTAINED). ON (B)(6) 2024, A POST-TRANSFUSION SAMPLE "(B)(6)" WAS COLLECTED AND TESTED ON ERYTRA 1807 (SN (B)(6), SOFTWARE VERSION 4.3.3) AT 09:45:36 WITH SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, ON DG GEL 8 ANTI-IGG CARDS LOT *018.01, EXP. 2025-03-31, AND A POSITIVE SCREENING RESULT WAS OBTAINED (CELL 1 (E-E+) WAS INTERPRETED AS 1+, THE CLAIMED CELL 2 (E+E) AS WELL AS THE CELL 3 (E-E+) WERE INTERPRETED AS NEGATIVE). THE SAMPLE WAS THEN TESTED ON ERYTRA 1837 AT 11:09:14 WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024017, EXP. 2024-09-28, ON DG GEL 8 ANTI-IGG CARDS LOT *018.01, EXP. 2025-03-31, AND ALL IDENTIFICATION RRBCS WERE INTERPRETED AS NEGATIVE INCLUDING CELL 4 (E+E+) AND CELL 10 (E+E-), EXCEPT CELL 8 (E-E+) WHICH HAD A "?" INTERPRETATION. THE AUTOCONTROL WAS POSITIVE (2+). ADDITIONALLY, DAT TESTING WAS PERFORMED ON THE SAME INSTRUMENT 1837 AT 11:27:00 USING THE SAME CARD LOT, AND A 3+ REACTION WAS OBTAINED. WITH SUBSEQUENT TESTING IN TUBE METHOD WITH IMMUCOR PEG ENHANCER (LOT 336049, EXP. 2026-03-27; 15 MIN INCUBATION AT 37°C), THE LABORATORY IDENTIFIED AN ANTI-E AS WELL AS AN USP (UNSPECIFIED POSITIVE) ANTIBODY: 1. SEARCH-CYTE TCS 3%, REF. 213631, LOT 644024017, EXP. 2024-09-28, WAS TESTED WITH THE PEG ENHANCER AND IN AHG THE CELL 2 (E+E-) WAS INTERPRETED AS 2+, WHILE CELL 1 AND CELL 3 (BOTH E-E+) WERE INTERPRETED AS NEGATIVE. THE AUTOCONTROL WAS NEGATIVE. 2. QUOTIENT ALBACYTE, REF. Z471U & Z472U, LOT V276076 & V276078, EXP. 2024-10-07, WAS TESTED WITH THE PEG ENHANCER AND IN AHG THE CELL 3 (E+E-) WAS INTERPRETED AS 1+, WHILE ALL THE OTHER CELLS (INCLUDING HETEROZYGOUS (E+E+) CELL 5) WERE INTERPRETED AS NEGATIVE. 3. SELECTED IMMUCOR RRBCS, LOT 31015, AS WELL AS THE PATIENT CELLS (AUTOCONTROL) WERE TESTED WITH THE PEG ENHANCER: CELL 6 (E+E-) WAS INTERPRETED AS 2+ IN IGG AND AS W+ IN IS (IMMEDIATE SPIN). CELL 7 (E+E-) WAS INTERPRETED AS 3+ IN IGG AND AS W+ IN IS (IMMEDIATE SPIN). CELL 8 (E+E-) WAS INTERPRETED AS 2+ IN IGG AND AS W+ IN IS (IMMEDIATE SPIN). CELLS 1, 2 AND 3 (E-E+) WERE INTERPRETED AS NEGATIVE (IGG AND IS). AUTOCONTROL WAS INTERPRETED AS 2+ IN IGG (NEGATIVE IN IS). ADDITIONALLY, ON (B)(6) 2024, THE SAMPLE WAS TESTED ON ERYTRA 1837 AT 16:08:11 WITH SELECTED CELL 9 (E+E-) OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024016, EXP. 2024-09-14, ON DG GEL 8 ANTI-IGG CARDS LOT *018.01, EXP. 2025-03-31, AND A 1+ REACTION WAS OBTAINED. THE LABORATORY CALLED THE FORMATION OF THE ANTIBODIES BY THE PATIENT A DELAYED SEROLOGICAL TRANSFUSION REACTION (THE TRANSFUSED UNIT WAS E+). NO ANTIGEN TYPING HAS BEEN PERFORMED ON THE PATIENT DUE TO THE RECENT TRANSFUSION. THE COMPLETE PHENOTYPE OF THE PRETRANSFUSION PATIENT SAMPLE AS WELL AS OF THE E+ BLOOD UNIT ((B)(6)) THAT WAS TRANSFUSED TO THE PATIENT, WERE REQUESTED TO THE CUSTOMER. ON 03 OCTOBER 2024, THE FOLLOWING INFORMATION WAS RECEIVED: RH PHENOTYPE OF THE BLOOD UNIT ((B)(6)) IS C+E+C+E+. NO PHENOTYPE INFORMATION IS AVAILABLE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313629 SEARCH-CYTE TCS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 644724016 07640137340384

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male