BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEARCH-CYTE TCS 0.8%

    MDR report key: 20187872 · Received September 11, 2024

    Report

    Report Number
    3002806769-2024-00005
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MEDION GRIFOLS DIAGNOSTICS AG,
    Product Code
    QHT
    UDI-DI
    07640137340384
    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 C+ RRBC (INCLUDING THE CLAIMED CELL 3), WHICH DOES NOT SUPPORT THE HYPOTHESIS OF AN ABNORMAL C ANTIGEN EXPRESSION OF THE CLAIMED CELL 3 AND DOES NOT DEMONSTRATE ANY MALFUNCTION OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724015, EXP. 2024-08-31. THUS, THE INVESTIGATIVE TESTING IS SUPPORTING THE HYPOTHESIS OF THE PRESENCE OF A LOW-TITER ANTI-C ANTIBODY IN THE PATIENT PLASMA THAT IS AT THE DETECTION LIMIT OF THE SYSTEM (NOTE: WHICH WAS DETECTED BY THE OTHER HOMOZYGOUS C+ CELL (I.E. CELL 2) OF THE CLAIMED PRODUCT). AS A CONCLUSION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED NEGATIVE REACTIONS WITH CELL 3 (DONOR (B)(6) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724015, EXP. 2024-08-31, IS SAMPLE RELATED, POINTING TO A LOW-TITER ANTI-C IN THE PATIENT PLASMA THAT IS AT THE DETECTION LIMIT OF THE GRIFOLS SYSTEM. THIS LOW ANTI-C 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 RESULT 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 SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724015, EXP. 2024-08-31.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS ON ERYTRA EFLEXIS FOR ONE PATIENT SAMPLE, OBTAINED WITH CELL 3 (C-C+, DONOR (B)(6) OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724015, EXP. 2024-08-31. ACCORDING TO THE INFORMATION IN THE WORK ORDER, THE SAMPLE "(B)(6)" (COLLECTION DATE UNSPECIFIED) ORIGINATES FROM A 71-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH PNEUMONIA. THE PATIENT DID NOT RECEIVE ANY RBCS UNITS AT CUSTOMER SITE AND HAD A HISTORY OF ANTI-C. THE CUSTOMER INDICATED THAT THEY DO NOT PERFORM ANTIBODY IDENTIFICATION ON THE INSTRUMENT BUT ARE USING ORTHO REAGENTS IN MANUAL. ON (B)(6) 2024, THE SAMPLE WAS TESTED ON ERYTRA EFLEXIS 0001847 V.1.2.5, USING SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724015, EXP. 2024-08-31, AND A "?" REACTION (MODIFIED TO 1+) WAS OBTAINED FOR CELL 2 (C-C+) WHILE THE CLAIMED CELL 3 (C-C+) WAS INTERPRETED AS NEGATIVE. THE ANTIBODY SCREENING WAS REPEATED USING ORTHO SURGISCREEN LOT VSS578, EXP. 2024-09-03, AND OBTAINED 2+ REACTIONS ON BOTH CELL 2 (C-C+) AND CELL 3 (C-C+). THE CUSTOMER THEN PROCEEDED TO ANTIBODY IDENTIFICATION USING SELECTED ORTHO REAGENT RED BLOOD CELLS (RRBC) FROM PANEL C LOT VRC326, EXP. 2024-09-03. CELL 2 (C+C-), CELL 11 (C+C-) AND AUTOCONTROL REACTED NEGATIVE, AND CELL 3 (C-C+) AS WELL AS CELL 4 (C-C+) WERE INTERPRETED AS 2+. CUSTOMER INDICATED THAT THE CARDS WERE INSPECTED BEFORE USAGE AND THAT THE REAGENTS WERE BROUGHT TO ROOM TEMPERATURE AND THE REAGENT RED BLOOD CELLS (RRBC) WELL MIXED BEFORE TESTING. THE QUALITY CONTROL WAS PERFORMED AND ACCEPTABLE FOR ALL CARDS AND REAGENTS USED AT THE DATE OF TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556472 SEARCH-CYTE TCS 0.8% REAGENT RED BLOOD CELLS FOR ANTIBODY IDENTIFICATION QHT MEDION GRIFOLS DIAGNOSTICS AG, N/A 644724015 07640137340384

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female