BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATA-CYTE PLUS 2 0.8%

    MDR report key: 20187890 · Received September 11, 2024

    Report

    Report Number
    3002806769-2024-00004
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MEDION GRIFOLS DIAGNOSTICS AG,
    Product Code
    QHT
    UDI-DI
    07640137341459
    PMA / PMN Number
    BL103898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ALL THE ELEMENTS, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS WITH CELL 1 (DONOR (B)(6) OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17, IS SAMPLE RELATED, POINTING TO A LOW-TITER ANTI-JKA IN THE PLASMA OF BOTH PATIENTS THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM (NOTE: FOR BOTH SAMPLES, THE ANTI-JKA WERE DETECTED BY THE OTHER HOMOZYGOUS JKA+ CELLS (I.E. CELL 5, CELL 7 AND CELL 10) OF THE CLAIMED PRODUCT). THESE LOW ANTI-JKA LEVELS IN THE PATIENTS PLASMA SAMPLES, 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 PRODUCT DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION RESULTS ON ERYTRA EFLEXIS FOR TWO PATIENTS SAMPLES WITH KNOWN ANTI-JKA, OBTAINED WITH CELL 1 (JKA+B-, DONOR (B)(6) OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17. SAMPLE "TB24-220-B116" THE SAMPLE WAS COLLECTED AND TESTED ON 07 AUGUST 2024 AND ORIGINATES FROM A 78 YEAR-OLD MALE (UNKNOWN DIAGNOSIS OR RELEVANT MEDICATION) WHO RECEIVED RBCS ON 22, 24 AND 30 JULY 2024 AND WITH A HISTORY OF ANTI-JKA. AFTER A 1+ POSITIVE SCREENING RESULT WITH CELL 1 USING SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643524014, EXP. 2024-08-17, AND DG GEL 8 ANTI-IGG CARDS, LOT *009.01, EXP. 2024-12-31, ANTIBODY IDENTIFICATION WAS PERFORMED ON ERYTRA EFLEXIS 0001285 USING THE CLAIMED DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17, WITH DG GEL 8 ANTI-IGG CARDS, LOT *009.01, EXP. 2024-12-31, AND THE FOLLOWING RESULTS WERE OBTAINED: - CELL 2, CELL 3, CELL 8 AND CELL 11 WERE JKA NEGATIVE AND INTERPRETED AS NEGATIVE - THE CLAIMED HOMOZYGOUS (JKA+B-) CELL 1 REACTED NEGATIVE - THE OTHER HOMOZYGOUS JKA+ CELLS (CELL 5, CELL 7 AND CELL 10) REACTED POSITIVE (1+) - THE HETEROZYGOUS JKA+ CELLS (CELL 4, CELL 6 AND CELL 9) WERE INTERPRETED AS NEGATIVE - THE AUTOCONTROL WAS INTERPRETED AS POSITIVE (1+) THE CUSTOMER DID NOT PERFORM A DAT TESTING ON THE SAMPLE. SAMPLE "TB24-226-B025" THE SAMPLE WAS COLLECTED AND TESTED ON 13 AUGUST 2024 AND ORIGINATES FROM A 52 YEAR-OLD MALE (UNKNOWN DIAGNOSIS OR RELEVANT MEDICATION) WHO RECEIVED RBCS ON 05 AUGUST 2024 BUT WITH NO ANTIBODY HISTORY. AFTER A 1+ POSITIVE SCREENING RESULT WITH CELL 1 USING SEARCH-CYTE PLUS 0.8%, REF. 213656, LOT 643524014, EXP. 2024-08-17, AND DG GEL 8 ANTI-IGG CARDS, LOT *009.01, EXP. 2024-12-31, ANTIBODY IDENTIFICATION WAS THEN PERFORMED (SAME INSTRUMENT, SAME GEL CARDS) USING THE CLAIMED DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17, AND THE FOLLOWING REACTIONS WERE OBTAINED: - THE JKA NEGATIVE CELLS (CELL 2, CELL 3, CELL 8 AND CELL 11) AS WELL AS THE AUTOCONTROL WERE NEGATIVE. - THE CLAIMED HOMOZYGOUS (JKA+B-) CELL 1 REACTED NEGATIVE - THE OTHER HOMOZYGOUS JKA+ CELLS (CELL 5, CELL 7 AND CELL 10) WERE INTERPRETED AS "?" AND MODIFIED TO W+ - THE HETEROZYGOUS JKA+ CELLS (CELL 4, CELL 6 AND CELL 9) WERE INTERPRETED AS NEGATIVE. THE REAGENTS SETS WERE LOADED ON INSTRUMENT ON EACH DAY OF USE AND ARE KEPT ONBOARD FOR THE DAY. CARDS ARE SPUN PRIOR TO LOADING ON INSTRUMENT AND INSPECTED UPON RECEIPT AND PRIOR TO LOADING ON THE INSTRUMENT. THE CUSTOMER REQUESTED TESTING OF THE CLAIMED CELL 1 OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17 FOR JKA ANTIGEN TO BE REPERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612185 DATA-CYTE PLUS 2 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 617024014 07640137341459

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male