BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATA-CYTE PLUS 0.8%

    MDR report key: 20075449 · Received August 27, 2024

    Report

    Report Number
    3002806769-2024-00001
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 27, 2024
    Manufacturer
    MEDION GRIFOLS DIAGNOSTICS AG,
    Product Code
    QHT
    UDI-DI
    07640137340285
    PMA / PMN Number
    BL103898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A LOW-TITER ANTI-S IN THE PATIENT PLASMA WITH S SPECIFICITY THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM, IN COMBINATION WITH NATURALLY OCCURRING VARIATIONS IN THE ANTIGEN DENSITY OF RBCS MAY BE THE CAUSE OF THE UNEXPECTED RESULTS OBSERVED BY THE CUSTOMER. GRIFOLS HAS NO INDICATION OF MALFUNCTION OF PRODUCT DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024013, EXP. 2024-08-03.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY IDENTIFICATION RESULTS ON ERYTRA INSTRUMENT FOR ONE PATIENT SAMPLE, OBTAINED WITH CELL 6 (S+, S-, K-) OF DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024013, EXP. 2024-08-03. THE SAMPLE "(B)(6)" ORIGINATE FROM AN 62-YEAR-OLD FEMALE PATIENT WITH DIAGNOSIS OF RECTAL CANCER, WITH NO TRANSFUSION HISTORY, BUT WITH A HISTORY OF ANTI-K AND ANTI-S ANTIBODIES AS WELL AS AN UNIDENTIFIED ANTIBODY. THE SAMPLE WAS COLLECTED ON (B)(6) 2024.THE CUSTOMER INDICATED THAT THE REAGENT RED BLOOD CELLS (RRBC) WERE ON BOARD OF THE INSTRUMENT ONLY WHEN NEEDED, AND ARE STORED IN A REFRIGERATOR WHEN THEY ARE NOT IN USE. THE GEL CARDS WERE INSPECTED PRIOR USE WITH NO BUBBLE NOR DISPLACED GEL OBSERVED. ON (B)(6) 2024, THE CUSTOMER PERFORMED ANTIBODY SCREENING OF SAMPLE "(B)(6)" ON ERYTRA 1321 USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724014, EXP. 2024-08-17, WITH DG GEL 8 ANTI-IGG CARD LOT *010.01 EXP 2024-12-31, AND CELL 1 (S+, S-, K-, COB+) AND CELL 2 (S-, S+, K+) REACTED POSITIVE WITH 2+ AND 3+, RESPECTIVELY. CELL 3 (S-, S+, K-) REACTED NEGATIVE. ON (B)(6) 2024, THE CUSTOMER PERFORMED AN ANTIBODY IDENTIFICATION ON ERYTRA 1320 WITH THE SAMPLE "(B)(6)" USING DATA-CYTE PLUS 0.8%, REF. 213654, LOT 610024013, EXP. 2024-08-03, WITH DG GEL 8 ANTI-IGG CARD LOT *010.01 EXP 2024-12-31. THE FOLLOWING RESULTS WERE OBTAINED: - CELL 2 (S+, S+, K+) REACTED 3+; - CELL 3 (S+, S-, K-) WAS INTERPRETED AS "?"; - CELL 4, CELL 7 AND CELL 11 (ALL S+, S+, K-) WERE INTERPRETED AS NEGATIVE; - CLAIMED CELL 6 (S+, S-, K-) WAS INTERPRETED AS NEGATIVE; - THE AUTOCONTROL WAS INTERPRETED AS NEGATIVE. FURTHERMORE, ON (B)(6) 2024, THE CUSTOMER PERFORMED ADDITIONAL TUBE TESTING WITH THE SAMPLE "(B)(6)" USING CELL 2 AND CELL 15 OF PANOCELL-20, LOT 22946, EXP. 2024-08-02, AND CELL 15 OF PANOCELL-20, LOT 25968, EXP. 2024-08-23 USING PEG AS ENHANCER: 1 DROP OF CELLS, 2 DROPS OF SAMPLE, AND 2 DROPS OF IMMUCOR PEG, LOT 336049, EXPIRY 2026-03-27, WERE USED FOR THESE TESTING. THE FOLLOWING RESULTS WERE OBTAINED: - CELL 2 OF PANOCELL-20, LOT 22946, EXP. 2024-08-02, (S+, S-, K-) REACTED 3+ AT AHG PHASE; - CELL 15 OF PANOCELL-20, LOT 22946, EXP. 2024-08-02, (S+, S-, K-) REACTED 2+ AT AHG PHASE; - CELL 15 OF PANOCELL-20, LOT 25968, EXP. 2024-08-23 (S-, S+, K-, COB+) REACTED 1+ AT AHG PHASE. ON (B)(6) 2024, THE SAMPLE "(B)(6)" WAS THEN RETESTED FOR ANTIBODY IDENTIFICATION ON ERYTRA 1320 WITH DATA-CYTE PLUS 2 0.8%, REF. 213641, LOT 617024014, EXP. 2024-08-17, ON DG GEL 8 ANTI-IGG CARD LOT *010.01 EXP 2024-12-31. THE FOLLOWING RESULTS WERE OBTAINED: - CELL 2 (S+, S-, K+) REACTED 3+; - CELL 4 AND CELL 5 (BOTH S+, S+, K-) WERE INTERPRETED AS "?" BUT MODIFIED TO W+ BY THE OPERATOR; - CELL 11 (S+, S-, K-) REACTED 1+; - THE AUTOCONTROL WAS INTERPRETED AS NEGATIVE. THE CUSTOMER IDENTIFIED ANTI-K, ANTI-S AND ANTI-COB ANTIBODIES IN THE PATIENT SAMPLE "(B)(6)". A VISUAL REVIEW OF THE TRACEABILITY REPORTS SHOWS REACTION GRADES THAT ARE VISUALLY CONSISTENT WITH THE REACTION GRADE ASSIGNMENTS FROM THE SOFTWARE ALGORITHM. RAW IMAGE FILES TAKEN DURING PRE-PROCESSING INTEGRITY CHECK AND POST-PROCESSING RESULTS READS WERE EVALUATED AND NO ABNORMALITIES WERE NOTED. THE AGGLUTINATION PATTERNS WERE CONSISTENT WITH THE SOFTWARE ALGORITHM REACTION GRADE ASSIGNMENTS. NO EVIDENCE OF INSTRUMENT ERRORS WAS PRESENT IN THE INSTRUMENT LOGS, AND DAILY QUALITY CONTROL SAMPLES PASSED AS EXPECTED ON THE DAYS OF TESTING. THE INCUBATION TIMES WERE ALL 15 MINUTES FOR ALL CELLS TESTED AND THE DISPENSED VOLUMES WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940600 DATA-CYTE PLUS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 610024013 07640137340285

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown