BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA EFLEXIS

    MDR report key: 23665183 · Received November 27, 2025

    Report

    Report Number
    3002772505-2025-00008
    Event Type
    Malfunction
    Date Received
    November 27, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 27, 2025
    Manufacturer
    DIAGNOSTIC GRIFOLS S.A.
    Product Code
    KSZ
    PMA / PMN Number
    BK170130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A VISUAL INSPECTION OF RAW IMAGE OF THE NEGATIVE RESULT OBTAINED IN ANTIBODY SCREENING, FOR MICROTUBE 2 WHICH CORRESPONDS TO CELL 2 OF THE SEARCH-CYTE TCS (LOT 644725030 EXP. DATE 08/11/2025) OF CARD (B)(6) WHICH CORRESPONDS TO DG GEL 8 ANTI-IGG CARDS (LOT 25010 EXP. DATE 12/2025) SOME SCATTERED CELLS ALONG THE MICROTUBE ABOVE A NON-FLAT PELLET CAN BE OBSERVED. THIS VERY WEAK REACTION WAS NOT DETECTED BY THE READER OF THE INSTRUMENT, BECAUSE IT IS AT THE DETECTION LIMIT OF THE INSTRUMENT. AN ANALYSIS OF THE IMAGE PROVIDED HAS BEEN CARRIED OUT AND THE ADJUSTMENT PARAMETERS OF THE READER OF THE IMPLICATED EFLEXIS SUCH AS ILLUMINATION LEVEL, WHITE BALANCE FACTORS AND CONVERSION FACTOR HAVE BEEN REVIEWED. ALL THE PARAMETERS ARE AS EXPECTED. THE SAME SAMPLE WAS TESTED WITH THE DATA-CYTE PLUS (LOT 25021 EXP. DATE 22/11/2025), OBTAINING NEGATIVE RESULTS FOR ALL CELLS EXCEPT CELL 11, WHICH SHOWED A 1+ REACTION. ADDITIONALLY, A NEGATIVE RESULT WAS OBTAINED FOR CELL 10, WHICH IS HOMOZYGOUS FOR E (EE+), AS WELL AS CELL 11. AN ANALYSIS OF THE IMAGES PROVIDED HAS BEEN CARRIED OUT AND THE ADJUSTMENT PARAMETERS OF THE READER OF THE IMPLICATED EFLEXIS DO NOT SHOW ANY ANOMALY. THE ADJUSTMENT PARAMETER VALUES SUCH AS ILLUMINATION LEVEL, WHITE BALANCE FACTORS AND CONVERSION FACTOR ARE AS EXPECTED. THE OBTAINED RESULTS ARE AS EXPECTED BASED ON CURRENT VISION ALGORITHMS AND, ACCORDING TO THE VALIDATED CRITERIA IMPLEMENTED IN EFLEXIS V3.2.2, THE MICROTUBES ARE CONSIDERED CORRECTLY CLASSIFIED. NOT ENOUGH POINTS HAVE BEEN DETECTED TO CONSIDER THE REACTIONS AS DOUBTFUL OR WEAK. THE OBTAINED RESULTS ARE AS EXPECTED BASED ON CURRENT VISION ALGORITHMS AND, ACCORDING TO THE VALIDATED CRITERIA IMPLEMENTED IN ERYTRA EFLEXIS SOFTWARE VERSION 3.2.2. FOR MICROTUBE 2 OF CARD (B)(6) WHICH CORRESPONDS TO SEARCH-CYTE TCS (LOT 644725030 EXP. DATE 08/11/2025) GRADED AS NEGATIVE AFTER A VISUAL INSPECTION IN WHICH THE TESTS WERE PERFORMED AND ITS CORRESPONDING RAW IMAGE, SOME SCATTERED CELLS ALONG THE MICROTUBE ABOVE A NON-FLAT PELLET CAN BE OBSERVED. THIS DOUBTFUL OR WEAK REACTION WAS NOT DETECTED BY THE READER OF THE INSTRUMENT BECAUSE IT IS AT THE LIMIT OF DETECTION OF THE INSTRUMENT. FOR MICROTUBE 2 OF CARD (B)(6) WHICH CORRESPONDS TO DATA-CYTE PLUS (LOT 25021 EXP. DATE 22/11/2025), CONTAINS VERY FEW SCATTERED FREE RBCS TO BE CLASSIFIED AS DOUBTFUL OR WEAK. AS STATED IN THE ERYTRA EFLEXIS IFU: THOSE CASES THAT ARE GIVEN BY THE AUTOMATED INSTRUMENTS AS NEGATIVE BUT THAT, AFTER AN ACCURATE VISUAL READING OF THE MICROTUBE, SHOW A PATTERN OF FEW BARELY VISIBLE SMALL SIZED AGGLUTINATED CELLS AT THE LOWER PART OF THE GEL COLUMN OR BARELY VISIBLE SCATTERED POINTS THROUGHOUT THE GEL COLUMN ALONG WITH A PELLET OF NON-AGGLUTINATED CELLS AT THE BOTTOM, MAY SIGNAL EITHER SPECIFIC OR UNSPECIFIC REACTIONS. THESE REACTION PATTERNS CAN BE CLASSIFIED AS NEGATIVE OR AS "DOUBTFUL" BY THE AUTOMATED INSTRUMENTS WITHOUT INDICATING ANY MALFUNCTION. THESE CASES ARE AT THE LIMIT OF THE SYSTEM SENSITIVITY. THE MANUFACTURING DOCUMENTATION OF SEARCH-CYTE TCS 0.8%, REF. (B)(4), (LOT 644725030, EXP. 08/11/2025), AND DATA-CYTE PLUS 0.8%, REF. (B)(4), (LOT 610025021, EXP. 22/11/2025), WERE REVIEWED AND NO DEVIATIONS WERE FOUND THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. ALL INTERNAL TESTS PERFORMED DURING THE MANUFACTURING PROCESS WERE WITHIN INTERNAL SPECIFICATIONS. NOTABLY, AT RELEASE TESTING, CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. (B)(4), (LOT 644725030, EXP. 08/11/2025), AS WELL AS CELL 4 AND CELL 10 OF DATA-CYTE PLUS 0.8%, REF. (B)(4), (LOT 610025021, EXP.22/11/2025), WERE TESTED WITH DG GEL 8 RH PHENO, REF.(B)(4), (LOT 24001.1, EXP.28/02/2026), AND STRONG POSITIVE REACTIONS WERE OBTAINED FOR THE E ANTIGEN. CELL 2 OF SEARCH-CYTE TCS 0.8%, REF. (B)(4), (LOT 644725030, EXP. 08/11/2025), WAS PREPARED WITH DONOR (B)(6). THE ENTRY TYPING OF DONOR (B)(6) WAS REVIEWED AND NO DEVIATION WAS FOUND. THE DONOR WAS INDEPENDENTLY TYPED FOR E ANTIGEN BY TWO LABORATORY TECHNICIANS WITH TWO ANTI-E AND POSITIVE REACTIONS WERE OBTAINED. CELL 4 AND CELL 10 OF DATA-CYTE PLUS 0.8%, REF. (B)(4), (LOT 610025021, EXP. 22/11/2025), WERE PREPARED WITH DONORS (B)(6), RESPECTIVELY. THE ENTRY TYPING OF DONORS (B)(6) WAS REVIEWED, AND NO DEVIATIONS WERE FOUND. THE DONORS WERE BOTH INDEPENDENTLY TYPED FOR E ANTIGEN BY TWO LABORATORY TECHNICIANS WITH TWO ANTI-E AND POSITIVE REACTIONS WERE OBTAINED. A COMPLAINT DATABASE SEARCH WAS PERFORMED, CONCLUDING THAT NO COMPLAINT FOR SEARCH-CYTE TCS 0.8%, REF. (B)(4), (LOT 644725030, EXP. 08/11/2025), NOR FOR DATA-CYTE PLUS 0.8%, REF. (B)(4), (LOT 610025021, EXP. 22/11/2025), HAS BEEN REGISTERED TO DATE BY MEDION GRIFOLS DIAGNOSTICS AG. INTERNAL STABILITY RECORDS OF SEARCH-CYTE TCS 0.8%, REF. (B)(4), (LOT 644725030, EXP. 08/11/2025), AND DATA-CYTE PLUS 0.8%, REF. (B)(4), (LOT 610025021, EXP. 22/11/2025), WERE REVIEWED AND THE EXPECTED RESULTS WERE OBTAINED AT ALL TESTED TIME POINTS. IN CONCLUSION, THERE WAS NO MALFUNCTION OF THE INSTRUMENT OR REAGENTS. THE RESULT IS CONSIDERED TO BE DUE TO A WEAK SAMPLE THAT IS AT THE LIMIT OF THE INSTRUMENT'S SENSITIVITY.

    Description of Event or Problem · 0

    ON (B)(6) 2025, UNEXPECTED NEGATIVE RESULTS WERE OBSERVED WHEN TESTING SAMPLE (B)(6), (WITH ANTI-E ANTIBODIES IDENTIFIED) IN CELL II OF THE SEARCH-CYTE TCS (LOT 644725030 EXP. DATE 08/11/2025) WITH DG GEL 8 ANTI-IGG CARDS (LOT 25010 EXP. DATE 12/2025) ON THE ERYTRA EFLEXIS SN (B)(6). ALTHOUGH A VERY WEAK AGGLUTINATION CAN BE OBSERVED VISUALLY, A NEGATIVE RESULT WAS INTERPRETED BY THE INSTRUMENT. LATER, THE SAME SAMPLE WAS TESTED WITH THE DATA-CYTE PLUS (LOT 25021 EXP. DATE 22/11/2025) ON THE ERYTRA EFLEXIS SN (B)(6), OBTAINING NEGATIVE RESULTS FOR ALL CELLS EXCEPT CELL 11, WHICH SHOWED A 1+ REACTION. ADDITIONALLY, A NEGATIVE RESULT WAS OBTAINED FOR CELL 10, WHICH IS HOMOZYGOUS FOR E (EE+), AS WELL AS CELL 11. HOWEVER, ON (B)(6) 2025, THE SAME SAMPLE WAS TESTED USING THE SAME REAGENT AND CARD, SEARCH-CYTE TCS (LOT 644725030 EXP. DATE 08/11/2025) AND DG GEL 8 ANTI-IGG CARDS (LOT 25010 EXP. DATE 12/2025) BUT ON TWO DIFFERENT INSTRUMENTS SN (B)(6). IN BOTH CASES, A '?' RESULT WAS OBTAINED FOR CELL II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2728056 ERYTRA EFLEXIS ERYTRA EFLEXIS KSZ DIAGNOSTIC GRIFOLS S.A. DG-511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown