BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATA-CYTE PLUS 2 0.8%

    MDR report key: 20123313 · Received September 3, 2024

    Report

    Report Number
    3002806769-2024-00003
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    July 30, 2024
    Report Date
    September 3, 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 8 (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-FYA IN THE PATIENT PLASMA WITH FYA SPECIFICITY THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS LOW ANTI-FYA 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. 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 FOR ONE PATIENT SAMPLE, OBTAINED WITH CELL 8 (FYA+B-, DONOR (B)(6) OF DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17. ACCORDING TO THE INFORMATION IN THE WORK ORDER, THE SAMPLE "(B)(6)" WAS COLLECTED ON (B)(6) 2024 AND ORIGINATES FROM A 42-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH CHRONIC MYELOGENOUS LEUKEMIA (CML). THE PATIENT RECEIVED 3 RBCS UNITS IN THE LAST 3 MONTHS AND HAS A HISTORY OF ANTI-FYA. THE CUSTOMER INDICATED THAT THE CLAIMED CELL REACTED WITH ANOTHER PATIENT SAMPLE WHO ALSO HAD AN ANTI-FYA. ON (B)(6) 2024, THE CUSTOMER PERFORMED ANTIBODY SCREENING OF SAMPLE "(B)(6)" ON ERYTRA 1320 USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724014, EXP. 2024-08-17, WITH DG GEL 8 ANTI-IGG CARD, LOT 24010.01, EXP. 2024-12-31. WHILE CELL 1 (FYA-B+) AND CELL 3 (FYA-B+) WERE NEGATIVE, CELL 2 (FYA+B-) REACTED POSITIVE (1+). THE CUSTOMER THEN PERFORMED ANTIBODY IDENTIFICATION OF THE SAMPLE ON THE SAME INSTRUMENT USING THE CLAIMED DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17, AND THE FOLLOWING RESULTS WERE OBTAINED: - THE FYA- CELLS (CELL 1, CELL 5, CELL 6, CELL 7 AND CELL 10) AS WELL AS THE AUTOCONTROL WERE NEGATIVE - THE CLAIMED HOMOZYGOUS (FYA+B-) CELL 8 REACTED NEGATIVE - THE OTHER HOMOZYGOUS (FYA+B-) CELL 3 REACTED POSITIVE (1+) - THE HETEROZYGOUS FYA+ CELLS (CELL 2, CELL 4, CELL 9 AND CELL 11) WERE INTERPRETED AS NEGATIVE ON (B)(6) 2024, THE CUSTOMER REPEATED THE ANTIBODY IDENTIFICATION ON ANOTHER ERYTRA INSTRUMENT 1321 WITH THE CLAIMED DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17, AND DG GEL 8 ANTI-IGG CARD LOT 24010.01, EXP. 2024-12-31. SIMILAR RESULTS TO THE INITIAL TESTING WERE OBTAINED. ON (B)(6) 2024, THE CUSTOMER REPEATED AGAIN THE ANTIBODY IDENTIFICATION ON THE INITIAL INSTRUMENT 1320 AS THE INITIAL TESTING USING THE CLAIMED DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17, WITH DG GEL 8 ANTI-IGG CARD LOT 24010.01, EXP. 2024-12-31, AND SIMILAR RESULTS WERE AGAIN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369562 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 42 YR Unknown