BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA EFLEXIS

    MDR report key: 21320084 · Received February 6, 2025

    Report

    Report Number
    3002772505-2025-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 1, 2025
    Report Date
    February 6, 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 4 OF CARD 414105250240104733 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 OBTAINED RESULT IS AS EXPECTED BASED ON CURRENT VISION ALGORITHMS AND, ACCORDING TO THE VALIDATED CRITERIA IMPLEMENTED IN ERYTRA EFLEXIS SOFTWARE VERSION 3.2.0, THE MICROTUBE IS CONSIDERED CORRECTLY CLASSIFIED AS NEGATIVE. SINCE NOT ENOUGH POINTS HAVE BEEN DETECTED TO CONSIDER THESE REACTIONS AS "+/-". FOR THIS REASON, THE IMAGE HAS BEEN CLASSIFIED AS NEGATIVE BY THE INSTRUMENT. 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. 213655, LOT 644724024, EXP. 2025-01-04, WAS 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. CELL 1 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724024, EXP. 2025-01-04, WAS PREPARED WITH DONOR (B)(6). DONOR (B)(6) IS A NEW DONOR AND WAS USED FOR THE FIRST TIME IN THE MANUFACTURING OF CELL 1 OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT LOT 644724024, EXP. 2025-01-04. THE ENTRY TYPING OF DONOR (B)(6) WAS REVIEWED AND NO DEVIATION WAS FOUND. THE DONOR WAS INDEPENDENTLY TYPED FOR JKA ANTIGEN BY TWO LABORATORY TECHNICIANS WITH TWO SINGLE SOURCE POLYCLONAL ANTISERA AND POSITIVE REACTIONS WERE OBTAINED. MOREOVER, THE DONOR WAS ALSO TYPED USING MDMULTICARD BASIC EXTENDED PHENOTYPE AND A CLEAR POSITIVE JKA RESULT WAS OBTAINED. A COMPLAINT DATABASE SEARCH WAS PERFORMED, CONCLUDING THAT NO OTHER COMPLAINT FOR SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724016, EXP. 2024-09-14, HAS BEEN REGISTERED TO DATE BY MEDION GRIFOLS DIAGNOSTICS AG. INTERNAL STABILITY RECORDS OF SEARCH-CYTE TCS 0.8%, REF. 213655, LOT 644724024, EXP. 2025-01-04, WERE REVIEWED AND THE EXPECTED RESULTS WERE OBTAINED AT ALL TESTED TIME POINTS THE FOLLOWING LIMITATION HAS BEEN INCLUDED IN ERYTRA EFLEXIS SOFTWARE VERSION 3.2.0 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." AS A MITIGATION, WHEN A USER DEEMS RELEVANT TO IDENTIFY RESULTS WITH THIS WEAK PATTERN IN A NEGATIVE RESULT, THE INSTRUMENT CAN BE CONFIGURED TO CONSIDER NEGATIVE RESULTS IN XMATCH AS SPECIAL RESULTS REQUIRING A REVIEW FROM THE USER. ADDITIONALLY, IMPROVEMENTS IN THE INTERPRETATION ALGORITHM OF THE VISION SYSTEM FOR THIS KIND OF PATTERNS WILL BE INCLUDED IN A FUTURE SOFTWARE VERSION.

    Description of Event or Problem · 0

    ON (B)(6), UNEXPECTED NEGATIVE RESULTS WERE OBSERVED WHEN TESTING SAMPLE (B)(6) WITH CELL 1 OF SEARCH-CYTE TCS LOT 644724024 (EXP. DATE 04/01/2025) USING DG GEL 8 ANTI-IGG CARDS (LOT 24024, EXP. DATE 05/2025) WITH ERYTRA EFLEXIS SN (B)(6). WHEN THE CUSTOMER TESTED THE SAME SAMPLE WITH DATA-CYTE PLUS LOT 24025 (EXP. DATE 18/01/2025), NEGATIVE RESULTS WERE OBTAINED FOR ALL CELLS EXCEPT FOR CELL 1, WHICH SHOWED A (?) QUESTIONABLE RESULT. THE CUSTOMER THEN MODIFIED THE RESULTS OF CELL 1 AND CELL 10 TO WEAK POSITIVE (W+). AN ANTI-JKA ANTIBODY WAS IDENTIFIED. HOWEVER, UPON VISUAL REVIEW OF THE MICROTUBE IMAGE, A WEAK REACTION IS OBSERVED. PATIENT DEMOGRAPHICS PROVIDED BY THE CUSTOMER INDICATED A 50-YEAR-OLD PATIENT DIAGNOSED WITH CRAMPING/BLEEDING AND A HISTORY OF ANTI-JKA. NO RELEVANT MEDICATIONS WERE LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623203 ERYTRA EFLEXIS ERYTRA EFLEXIS KSZ DIAGNOSTIC GRIFOLS S.A. DG-511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown