BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE TCS 0.8%

    MDR report key: 20094396 · Received August 29, 2024

    Report

    Report Number
    3002806769-2024-00002
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 29, 2024
    Manufacturer
    MEDION GRIFOLS DIAGNOSTICS AG,
    Product Code
    QHT
    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+ RRBC (INCLUDING THE CLAIMED CELL 2), WHICH DOES NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL E ANTIGEN EXPRESSION OF THE CLAIMED CELL 2 AND DOES NOT DEMONSTRATE ANY MALFUNCTION OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724014, EXP. 2024-08-17. 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 2 (DONOR (B)(6) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724014, EXP. 2024-08-17, 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. MEDION GRIFOLS DIAGNOSTICS AG HAS NO INDICATION OF MALFUNCTION OF PRODUCT SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724014, EXP. 2024-08-17.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS ON ERYTRA EFLEXIS FOR ONE PATIENT SAMPLE, OBTAINED WITH CELL 2 (E+, E-) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724014, EXP. 2024-08-17. ACCORDING TO THE INFORMATION IN THE WORK ORDER, THE SAMPLE "I7261409PK" ORIGINATE FROM AN 36-YEAR-OLD PREGNANT FEMALE PATIENT WITH UNKNOWN TRANSFUSION HISTORY, BUT WITH A HISTORY OF ANTI-E ANTIBODIES. THE SAMPLE WAS COLLECTED ON 26 JULY 2024. THE CUSTOMER INDICATED THAT THE GEL CARDS WERE INSPECTED PRIOR USE WITH NO BUBBLE NOR DISPLACED GEL OBSERVED. ON 26 JULY 2024, THE CUSTOMER PERFORMED ANTIBODY SCREENING OF SAMPLE "I7261409PK" ON ERYTRA EFLEXIS 0000988 USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724014, EXP. 2024-08-17, WITH DG GEL 8 ANTI-IGG CARD LOT 24005.01, EXP 2024-12-31, AND CELL 1 (E-, E+), CELL 2 (E+, E-), AND CELL 3 (E-, E+), REACTED NEGATIVE. ON 31 JULY 2024, THE CUSTOMER REPEATED THE ANTIBODY SCREENING OF SAMPLE "I7261409PK" ON ERYTRA EFLEXIS 0000988 USING A NEW KIT OF 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, AND CELL 1 (E-, E+), CELL 2 (E+, E-), AND CELL 3 (E-, E+), REACTED NEGATIVE. ON 31 JULY 2024, THE CUSTOMER PERFORMED ANTIBODY SCREENING OF SAMPLE "I7261409PK" IN MANUAL GEL METHOD USING ORTHO SURGISCREEN 0.8% CELLS,LOT VS569, EXP. 2024-08-06, WITH ORTHO ANTI-IGG CARDS, LOT F021924001-15, EXP. 2024-12-19. 50 L OF CELLS AND 25 L OF SAMPLE WERE USED FOR THESE TESTING. IT WAS INCUBATED 15 MIN AT 37°C. CELL 2 (E+, E-) REACTED 1-2+. CELL 1 (E-, E+) AND CELL 3 (E-, E+) REACTED NEGATIVE. ACCORDING TO L2 INVESTIGATION, 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. CELL 2 HAD AN IRREGULARLY SHAPED NEGATIVE BUTTON WITH SLIGHT AGGLUTINATION IN THE GEL COLUMN, BUT NOT ENOUGH FOR THE REACTION TO BE CONSIDERED A "?" RESULT. NO EVIDENCE OF INSTRUMENT ERRORS WAS PRESENT IN THE INSTRUMENT LOGS, AND DAILY QUALITY CONTROL SAMPLES PASSED AS EXPECTED ON THE DAYS OF TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231867 SEARCH-CYTE TCS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 644724014

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Unknown