BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA EFLEXIS

    MDR report key: 23435442 · Received October 31, 2025

    Report

    Report Number
    3002772505-2025-00007
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 5, 2025
    Report Date
    October 31, 2025
    Manufacturer
    DIAGNOSTIC GRIFOLS, S.A.
    Product Code
    KSZ
    PMA / PMN Number
    BK230820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS CONDUCTED AT DIAGNOSTIC GRIFOLS S.A. FOLLOWING THE REPORT OF UNEXPECTED NEGATIVE RESULTS OBTAINED WITH THE ERYTRA EFLEXIS INSTRUMENT. BASED ON THE IMAGES PROVIDED BY THE CUSTOMER, THE ADJUSTMENT PARAMETERS OF THE READER DID NOT SHOW ANY ANOMALIES. THE ADJUSTMENT PARAMETER VALUES LIKE ILLUMINATION LEVEL, WHITE BALANCE FACTORS AND CONVERSION FACTOR ARE AS EXPECTED. ADDITIONALLY, THE ANALYSIS OF RAW IMAGES FROM THE INTEGRITY CHECK CONFIRMED THAT THE CARDS WERE IN CORRECT CONDITION, WITH NO BUBBLES, SPLASHES, OR OTHER IRREGULARITIES OBSERVED IN THE INCUBATION CHAMBER. A REVIEW OF THE INSTRUMENT LOGS REVEALED NO ERRORS DURING THE EXECUTION OF BOTH THE IDENTIFICATION PANEL AND CROSSMATCH TESTS. THE INCUBATION PROCESS FOR BOTH CARDS AND REAGENTS WAS COMPLETED CORRECTLY, WITH NO DEVIATIONS OR INCIDENTS RECORDED. AN IN-DEPTH ANALYSIS OF THE REPORTED IMAGES WAS PERFORMED. IN THE CASE OF MICROTUBE 3 OF CARD (B)(6) OF THE IDENTIFICATION PANEL, WHICH WAS GRADED AS NEGATIVE, A PELLET AND A FEW SMALL-SIZED AGGLUTINATES WERE OBSERVED IN THE LOWER HALF OF THE MICROTUBE. HOWEVER, THIS PATTERN WAS INSUFFICIENT TO CLASSIFY THE REACTION AS DOUBTFUL OR WEAK. IN MICROTUBE 6 OF CARD (B)(6) OF THE CROSSMATCH TEST AND MICROTUBE 7 OF CARD (B)(6), AND MICROTUBE 1 OF CARD (B)(6), BOTH OF THE IDENTIFICATION PANEL, ALL GRADED AS NEGATIVE, VISUAL INSPECTION REVEALED A PELLET AND SMALL-SIZED AGGLUTINATES IN THE LOWER HALF OF THE MICROTUBE. THESE BORDERLINE REACTIONS, WHICH LIE BETWEEN A NEGATIVE AND A "+/-" RESULT, WERE NOT DETECTED BY THE INSTRUMENT READER DUE TO BEING AT THE LIMIT OF ITS DETECTION CAPABILITY. ACCORDING TO THE VISION ALGORITHM IN ERYTRA EFLEXIS SOFTWARE VERSION 3.2.2, THESE REACTIONS WERE CLASSIFIED AS NEGATIVE. THE CUSTOMER SUSPECTS THE PRESENCE OF AN ANTI-M ANTIBODY. ACCORDING TO THE DG GEL COOMBS CARD INSTRUCTIONS FOR USE (IFU), OPTIMAL REACTION CONDITIONS, SUCH AS SAMPLE VOLUME OR INCUBATION TIME, MAY VARY DEPENDING ON ANTIBODY SPECIFICITY. FOR EXAMPLE, INCREASING THE PLASMA VOLUME FROM 25 L TO 50 L IS ACCEPTABLE TO ENHANCE TEST SENSITIVITY, PARTICULARLY FOR SCREENING AND IDENTIFICATION OF UNEXPECTED ANTIBODIES OR CROSSMATCH TESTING. SINCE ANTI-M IS A COLD-REACTIVE ANTIBODY, INCUBATION AT ROOM TEMPERATURE MAY BE RECOMMENDED AS AN INVESTIGATIVE TECHNIQUE TO FACILITATE ITS DETECTION. ON THE OTHER HAND, CASES WHERE AUTOMATED INSTRUMENTS REPORT A NEGATIVE RESULT BUT VISUAL INSPECTION REVEALS A FEW BARELY VISIBLE AGGLUTINATED CELLS AT THE BOTTOM OF THE GEL COLUMN, OR SCATTERED POINTS THROUGHOUT THE COLUMN ALONG WITH A PELLET OF NON-AGGLUTINATED CELLS, MAY INDICATE EITHER SPECIFIC OR NONSPECIFIC REACTIONS. THESE PATTERNS ARE AT THE LIMIT OF SYSTEM SENSITIVITY AND MAY BE CLASSIFIED AS NEGATIVE OR "DOUBTFUL" BY THE INSTRUMENT WITHOUT INDICATING ANY MALFUNCTION. THE FOLLOWING LIMITATION IS INCLUDED IN THE ERYTRA EFLEXIS IFU, SECTION 1.3 PRODUCT LIMITATIONS: "RESULTS 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 INSTRUMENT SENSITIVITY." PRIOR TO PERFORMING A CROSSMATCH TEST, A FULL BATTERY OF TESTS, INCLUDING ABO-RH TYPING, ANTIBODY SCREENING, AND ANTIBODY IDENTIFICATION, SHOULD BE CONDUCTED TO ENSURE THE SUITABILITY OF THE BLOOD. ANY INCOMPATIBILITY SHOULD BE DETECTED BEFORE THE CROSSMATCH. IF THE PATIENT'S ANTIBODY IS TOO WEAK TO DETECT A WEAK ANTIGEN ON THE DONOR'S RBCS, IT IS UNLIKELY TO CAUSE A SERIOUS IMMEDIATE REACTION AND MAY ONLY RESULT IN A MILD HEMOLYTIC TRANSFUSION REACTION IF THE IMMUNE RESPONSE IS STIMULATED. AS A MITIGATION MEASURE, WHEN A USER CONSIDERS IT RELEVANT TO IDENTIFY WEAK PATTERNS IN A NEGATIVE RESULT, THE INSTRUMENT CAN BE CONFIGURED TO TREAT NEGATIVE RESULTS IN CROSSMATCH TESTS AS SPECIAL RESULTS REQUIRING USER REVIEW. FURTHERMORE, IMPROVEMENTS TO THE INTERPRETATION ALGORITHM OF THE VISION SYSTEM FOR THESE TYPES OF PATTERNS ARE PLANNED FOR A FUTURE SOFTWARE VERSION.

    Description of Event or Problem · 0

    ON (B)(6), THE CUSTOMER REPORTED ONE UNEXPECTED NEGATIVE RESULT IN A CROSSMATCH TEST FOR PATIENT SAMPLE ID (B)(6) WITH DONOR SAMPLE ID (B)(6) USING DG GEL COOMBS CARD LOT 25090.01 (EXP. DATE 04/30/2026) WITH AN ERYTRA EFLEXIS INSTRUMENT. A COMPATIBLE RESULT WAS OBTAINED DESPITE A VERY WEAK AGGLUTINATION IS OBSERVED (CARD (B)(6) MICROTUBE 6). THE TESTED PATIENT SAMPLE WAS CONFIRMED TO BE BLOOD GROUP O POSITIVE. PRIOR TO PERFORMING THE CROSSMATCH, THE CUSTOMER CONDUCTED AN ANTIBODY SCREENING, WHICH YIELDED A POSITIVE REACTION (+1) WITH CELL I OF SERASCAN DIANA 3 LOT 25025.01 (EXP. DATE11/01/2025) USING DG GEL COOMBS CARD, LOT 25090.01. SUBSEQUENTLY, AN ANTIBODY IDENTIFICATION PANEL WAS PERFORMED USING IDENTISERA DIANA, LOT 25017.01 (EXP. DATE 10/21/2025), ALONG WITH THE SAME DG GEL COOMBS CARD LOT. ALTHOUGH THE INSTRUMENT INTERPRETED ALL MICROTUBES AS NEGATIVE, THE CUSTOMER OBSERVED, BASED ON VISUAL INSPECTION, THAT CELL 3 (CARD (B)(6) MICROTUBE 3) SHOWED A BORDERLINE REACTION, AND CELLS 7 (CARD (B)(6) MICROTUBE 7) AND 9 COULD BE INTERPRETED AS "+/-" (CARD (B)(6) MICROTUBE 1). ALTHOUGH THE ANTIBODY IDENTIFICATION STUDY WAS INCONCLUSIVE, THE CUSTOMER SUSPECTS THE POSSIBLE PRESENCE OF ANTI-M ANTIBODIES IN THE SAMPLE. ON THE OTHER HAND, THE DONOR UNIT (B)(6) HAS AN ABO GROUP O NEGATIVE AND THE FOLLOWING EXTENDED PHENOTYPE: C- C+ D- E- E+ K- K+ FYA+ FYB+ JKA+ JKB+ M+ N- S+ S+ P1- LEA- LEB+ LUA- LUB+ KPA- KPB+ CW-. THE DONOR UNIT WAS NOT TRANSFUSED TO THE PATIENT. THE DISCREPANCY IN THE RESULTS WAS IDENTIFIED PRIOR TO THE TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085609 ERYTRA EFLEXIS AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM KSZ DIAGNOSTIC GRIFOLS, S.A. DG-511

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other