BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA EFLEXIS

    MDR report key: 20321772 · Received September 27, 2024

    Report

    Report Number
    3002772505-2024-00006
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 9, 2024
    Report Date
    September 9, 2024
    Manufacturer
    DIAGNOSTIC GRIFOLS S.A.
    Product Code
    KSZ
    PMA / PMN Number
    BK230820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A VISUAL INSPECTION OF THE REPORTED MICROTUBES IN WHICH THE CROSSMATCH TEST WAS PERFORMED AND THEIR CORRESPONDING RAW IMAGES, A FEW SCATTERED CELLS ALONG THE MICROTUBES ABOVE A NON-FLAT PELLET CAN BE OBSERVED. THESE WEAK REACTIONS WERE NOT DETECTED BY THE READER OF THE INSTRUMENT BECAUSE THEY ARE AT THE LIMIT OF DETECTION OF THE INSTRUMENT. AN ANALYSIS OF THE IMAGES PROVIDED HAS BEEN CARRIED OUT AND THE ADJUSTMENT PARAMETERS OF THE READER EMBEDDED IN 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 ERYTRA EFLEXIS VERSION 2.1.0, THE MICROTUBES ARE CONSIDERED CORRECTLY CLASSIFIED AS NEGATIVE. FOR THESE MICROTUBES, NOT ENOUGH POINTS HAVE BEEN DETECTED TO CONSIDER THE REACTION AS WEAK OR DOUBTFUL. 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. ADDITIONALLY, PRIOR TO THE CROSSMATCH TEST, A BATTERY OF TESTS AS ABO-RH TYPING, ANTIBODY SCREENING AND ANTIBODY IDENTIFICATION SHOULD BE PERFORMED TO ENSURE THE SUITABILITY OF THE BLOOD. THEREFORE, THE SUITABILITY OF THE BLOOD TO BE TRANSFUSED TO THE PATIENT SHOULD BE ENSURED BEFORE THE CROSSMATCH TEST AND ANY INCOMPATIBILITY SHOULD BE ALREADY FOUND. IF THE PATIENT'S ANTIBODY IS TOO WEAK TO DETECT THE WEAK ANTIGEN ON THE DONOR'S RBCS IT IS UNLIKELY TO CAUSE A SERIOUS IMMEDIATE REACTION IN THE PATIENT AND WILL PROBABLY ONLY CAUSE A MILD HEMOLYTIC TRANSFUSION REACTION IF THE PATIENT'S IMMUNE RESPONSE IS STIMULATED. THE FOLLOWING LIMITATION WILL BE INCLUDED IN ERYTRA EFLEXIS 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

    THE CUSTOMER COMPLAINS THAT THE EFLEXIS DID NOT MARK THE MICROTUBE RESULTS AS +/- OR? , ALTHOUGH THEY SHOW WEAK POSITIVE REACTIONS IN THE MICROTUBES 5 AND 7 WHEN EXECUTING A CROSSMATCH TEST TECHNIQUE OF THE CARD (B)(6). SOME SCATTERED CELLS ABOVE A NON-FLAT PELLET CAN BE OBSERVED IN WELLS 5 AND 7 OF CARD (B)(6). NO ERRORS DURING THE EXECUTION OF THE TECHNIQUES WERE DETECTED AND THE CLINICAL HISTORY INFORMATION OF THE PATIENT (ID (B)(6)) IS NOT AVAILABLE. ON THE OTHER HAND, IT IS INDICATED THAT THE INCIDENT WAS DETECTED BEFORE TRANSFUSION AND NEVER INFLUENCE TRANSFUSION BECAUSE THIS INSTRUMENT IS ON VALIDATION PROCESS (NOT IN ROUTINE TESTING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830402 ERYTRA EFLEXIS ERYTRA EFLEXIS KSZ DIAGNOSTIC GRIFOLS S.A. DG-511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown