BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATA-CYTE PLUS 0.8%

    MDR report key: 20426303 · Received October 11, 2024

    Report

    Report Number
    3002806769-2024-00007
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 11, 2024
    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 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 644724018, EXP. 2024-10-12, 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 DATA-CYTE PLUS 0.8%, REF. 213654, LOT 644724017, EXP. 2024-09-28, AND SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12. 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 SYSTEM. AS A CONCLUSION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS WITH 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, AS WELL AS WITH CELL 2 (DONOR (B)(6) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12, IS SAMPLE RELATED, POINTING TO A 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 DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024017, EXP. 2024-09-28, AND SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY/IDENTIFICATION RESULTS FOR ONE PATIENT, OBTAINED 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), AS WELL AS WITH CELL 2 (E+E-) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12 (UDI: (B)(4). ACCORDING TO THE INFORMATION IN THE WORK ORDER, TWO SAMPLES WERE COLLECTED ON 11 SEPTEMBER (SAMPLE (B)(6) AND 17 SEPTEMBER 2024 (SAMPLE (B)(6) AND ORIGINATE FROM A 32-YEAR-OLD FEMALE PATIENT (PREPROCEDURAL EXAM FOR HYSTERECTOMY) WITH NO RELEVANT MEDICATION. THE PATIENT HAS NO TRANSFUSION HISTORY BUT AN HISTORICAL ANTI-E. ON 11 SEPTEMBER 2024, THE SAMPLE "N381247841" WAS TESTED AT THE CUSTOMER SISTER FACILITY (B)(6) ON ERYTRA EFLEXIS (SN (B)(6) WITH SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, ON DG GEL 8 ANTI-IGG CARDS, LOT 24010.01, EXP. 2024-12-31, AND CELL 2 (E+E-) WAS INTERPRETED AS "?" (BUT MODIFIED TO 1+ BY THE OPERATOR) WHILE CELL 1 AND CELL 3 (BOTH E-) REACTED NEGATIVE. THE SAMPLE WAS TESTED ON 12 SEPTEMBER 2024 AT CUSTOMER SITE (B)(6) HOSP ALBQ) ON ERYTRA (SN (B)(6) WITH DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024017, EXP. 2024-09-28, ON DG GEL 8 ANTI-IGG CARDS, LOT 24014.01, EXP. 2025-03-31, AND ALL IDENTIFICATION PANEL CELLS, INCLUDING CELL 4 (E+E+) AND CELL 10 (E+E-) AS WELL AS THE AUTOCONTROL, WERE INTERPRETED AS NEGATIVE. THE SAMPLE WAS THEN TESTED WITH SOLID PHASE ALTERNATIVE METHOD ON IMMUCOR ECHO USING CAPTURE-R READY-ID STRIP, ID 013, LOT ID476, EXP. 2024-11-05, WITH CAPTURE LISS ENHANCER (15 MIN INCUBATION AT 37°C), ID 211, LOT 686, EXP. 2024-09-27. CELL 3 (E+E-) WAS INTERPRETED AS 1+ AND CELL 6 (E+E+) WAS INTERPRETED AS NEGATIVE BY THE INSTRUMENT BUT MODIFIED TO W+ BY THE OPERATOR. THE OTHER CELLS (INCLUDING THE OTHER HETEROZYGOUS CELL 1) WERE NEGATIVE. ON 17 SEPTEMBER 2024, THE SAMPLE "N381390636" WAS TESTED AT THE CUSTOMER SISTER FACILITY ON ERYTRA EFLEXIS (SN (B)(6) WITH SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724018, EXP. 2024-10-12, ON DG GEL 8 ANTI-IGG CARDS LOT 24010.01, EXP. 2024-12-31, AND ALL SCREENING CELLS INCLUDING CELL 2 (E+E-) WERE INTERPRETED AS NEGATIVE. THE CUSTOMER STATED THAT THE TESTS WERE NOT RETESTED NEITHER WITH NEW KIT OF THE SAME RRBCS, NEW LOT OF RRBCS, NEW BOX OF THE SAME LOT OF CARDS, OR NEW LOT OF CARDS. THE CARDS WERE NOT CENTRIFUGED BEFORE LOADING ON THE INSTRUMENT BUT WERE INSPECTED FOR DISPLACED GEL/SUPERNATANT OR BUBBLES UPON RECEIPT AND INSPECTED BEFORE LOADING ON THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312681 DATA-CYTE PLUS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 610024017 07640137340285

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female