BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA

    MDR report key: 23876546 · Received December 23, 2025

    Report

    Report Number
    3002772505-2025-00009
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 23, 2025
    Manufacturer
    DIAGNOSTIC GRIFOLS S.A.
    Product Code
    KSZ
    PMA / PMN Number
    BK170130
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE IMAGE PROVIDED, THE ADJUSTMENT PARAMETERS OF THE READER FOR THE IMPLICATED ERYTRA INSTRUMENT DO NOT SHOW ANY ANOMALY. THE ADJUSTMENT PARAMETER VALUES LIKE ILLUMINATION LEVEL, WHITE BALANCE FACTORS AND CONVERSION FACTOR ARE AS EXPECTED. AN ANALYSIS OF THE REPORTED IMAGES FOR BOTH THE DAT TEST AND THE CROSSMATCH TEST HAS BEEN CONDUCTED. BOTH TESTS WERE REVIEWED, AND NO ANOMALIES WERE DETECTED IN THE DAT TEST RESULTS. IN MICROTUBE 5 OF CARD (B)(6), CORRESPONDING TO A CROSSMATCH TEST AND GRADED AS NEGATIVE, VISUAL INSPECTION REVEALS A NON-FLAT PELLET AND SOME SCATTERED CELLS ALONG THE MICROTUBE. THE RESULTS OBTAINED ARE AS EXPECTED BASED ON THE CURRENT VISION ALGORITHMS IMPLEMENTED IN THIS SOFTWARE VERSION. FOR THESE MICROTUBE, NOT ENOUGH POINTS HAVE BEEN DETECTED TO CONSIDER THE REACTION AS +/- OR DOUBTFUL "?". THIS WEAK REACTION WAS NOT DETECTED BY THE READER OF THE INSTRUMENT BECAUSE IT IS AT THE LIMIT OF DETECTION OF THE INSTRUMENT. THE ANALYSIS OF THE INTEGRITY CHECK RAW IMAGE CONFIRMS THAT THE STATUS OF THE CARD IS CORRECT, SINCE NO BUBBLES, SPLASHES, OR OTHER IRREGULARITIES WERE OBSERVED ON THE INCUBATION CHAMBER. MOREOVER, A REVIEW OF THE INSTRUMENT LOGS SHOWS NO ERRORS DURING THE EXECUTION OF BOTH TESTS: THE DAT TEST AND THE CROSSMATCH TEST. THE INCUBATION PROCESS FOR CARDS AND REAGENTS WAS COMPLETED CORRECTLY, WITH NO DEVIATIONS OR INCIDENTS RECORDED. DUE TO THE UNAVAILABILITY OF THE PATIENT'S SAMPLE, A MORE IN-DEPTH INVESTIGATION COULD NOT BE CARRIED OUT. 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. AS STATED IN ERYTRA INSTRUCTIONS FOR USE (IFU) IN 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." HOWEVER, THE MICROTUBE IMAGES HAVE BEEN STORED IN OUR DATABASE TO BE USED TO ASSESS FUTURE IMPROVEMENTS IN THE INTERPRETATION ALGORITHM OF THE VISION SYSTEM OF THE INSTRUMENT FOR THIS KIND OF PATTERNS.

    Description of Event or Problem · 0

    ON DECEMBER 3RD, A CROSSMATCH TEST WAS PERFORMED USING RECIPIENT SAMPLE: (B)(6) AND DONOR SAMPLE: (B)(6), WITH DG GEL COOMBS CARD LOT 25135.01 (EXP. DATE: 30/06/2026). THE TEST WAS RUN ON AN ERYTRA INSTRUMENT (SN: (B)(6), SOFTWARE VERSION 4.6.1), WHICH REPORTED A NEGATIVE RESULT IN MICROTUBE 5 OF CARD NUMBER (B)(6), BUT THE CUSTOMER MODIFIED IT TO "M1+". THE RECIPIENT SAMPLE ID: (B)(6) CORRESPONDS TO A COMPLICATED PATIENT WITH SUSPECTED AUTOIMMUNE DISEASE. IGG AUTOANTIBODY WAS DETECTED ON THE PATIENT'S ERYTHROCYTES; CLINICALLY SIGNIFICANT IGG SUBCLASSES (IGG1, IGG3) AND COMPLEMENT COMPONENTS WERE NEGATIVE. POSITIVE REACTIONS SUGGEST POSSIBLE AUTOANTI-D AND ALLOANTI-E ANTIBODIES. NO COLD ANTIBODIES WERE DETECTED. SERUM WAS ABSORBED WITH CELLS BEFORE PERFORMING CROSSMATCH ON ERYTRA. ADDITIONAL ANTIBODIES OR INTERFERING FACTORS CANNOT BE EXCLUDED. DIRECT ANTIGLOBULIN TEST (DAT) RESULTS FOR DONOR SAMPLE ID: (B)(6) IS NOT AVAILABLE. ON THE SAME 3RD OF DECEMBER, ANOTHER CROSSMATCH TEST WAS PERFORMED USING RECIPIENT SAMPLE: (B)(6) AND DONOR SAMPLE: (B)(6), WITH DG GEL COOMBS CARD LOT 25135.01 (EXP. DATE: 30/06/2026). THE TEST WAS RUN ON THE SAME ERYTRA INSTRUMENT, WHICH REPORTED A WEAK POSITIVE RESULT ("+/-"). ON (B)(6), AN ANTIBODY SCREENING BOTH IN NATIVE AND IN ENZYME WITH PAPAIN WERE PERFORMED TO PATIENT SAMPLE ID: (B)(6), WITH A NEGATIVE RESULT. THEREFORE, ANTIBODY IDENTIFICATION WAS NOT CARRIED OUT. PATIENT WAS DIAGNOSED WITH DIFFUSE LARGE B-CELL LYMPHOMA. ADDITIONALLY, A DAT WAS PERFORMED FOR DONOR SAMPLE: (B)(6) WITH DG GEL COOMBS CARD LOT 25135.01 (EXP. DATE: 30/06/2026). THE TEST WAS RUN ON THE SAME ERYTRA INSTRUMENT, WHICH REPORTED A NEGATIVE RESULT IN MICROTUBE 2 OF CARD NUMBER (B)(6), BUT THE CUSTOMER MODIFIED IT TO A WEAK POSITIVE RESULT ("M+/-"). FOR DONOR SAMPLE: (B)(6), RE-EXAMINATION OF THE SEGMENT AND THE PRODUCT BAG ERD C20012510837110 IN THE IMMUNOHEMATOLOGY LABORATORY ON DECEMBER 4TH, REVEALED SENSITIZATION OF ERYTHROCYTES (DAT POSITIVE). SO, THE TRANSFUSION PRODUCT ERD C20012510837110 WAS DISCARDED. IT IS MOST PROBABLY THAT THE WEAK DAT REACTIVITY OF THE BAG WAS THE CAUSE OF THE UNSPECIFIC RESULT IN THE CROSSMATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829762 ERYTRA ERYTRA KSZ DIAGNOSTIC GRIFOLS S.A. DG-059 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown