BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA EFLEXIS

    MDR report key: 20256786 · Received September 19, 2024

    Report

    Report Number
    3002772505-2024-00005
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 19, 2024
    Manufacturer
    DIAGNOSTIC GRIFOLS S.A.
    Product Code
    KSZ
    PMA / PMN Number
    BK170130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, SOME SCATTERED CELLS AT THE LOWER HALF OF 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 ERYTRA SUCH AS ILLUMINATION LEVEL, WHITE BALANCE FACTORS AND CONVERSION FACTOR HAVE BEEN REVIEWED. ALL THE PARAMETERS ARE AS EXPECTED EXCEPT FOR THE ERROR IN THE CONVERSION FACTOR WHICH IS HIGHER THAN EXPECTED. HOWEVER, THIS ERROR DOES NOT HAVE ANY IMPACT ON THE RESULT, THE CORRECTION OF THE CONVERSION FACTOR WOULD NOT MODIFY THE RESULT OBTAINED. NEVERTHELESS, A READJUSTMENT OF THE INSTRUMENT IS RECOMMENDED. THE OBTAINED RESULT IS AS EXPECTED BASED ON CURRENT VISION ALGORITHMS AND, ACCORDING TO THE VALIDATED CRITERIA IMPLEMENTED IN ERYTRA EFLEXIS SOFTWARE VERSION 1.2.5, 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 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)2024, THE CUSTOMER OBTAINED A NEGATIVE RESULT IN THE 2-CELL SCREENING CELL (SEARCH-CYTE TCS 0.8% RRBC, LOT 644724016) WHEN TESTED ON THE EFLEXIS (511-0000883 V.1.2.5) ONE FRESH EDTA PATIENT SAMPLE (ID (B)(6). HOWEVER, UPON VISUAL REVIEW OF THE MICROTUBE IMAGE, A WEAK REACTION IS OBSERVED. THE PATIENT IS A 60-YEAR-OLD FEMALE WITH AN UNKNOWN DIAGNOSIS. THE PATIENT RECEIVED 1 UNIT OF RBCS IN 2021 AND HAS A HISTORY OF ANTI-E ANTIBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746441 ERYTRA EFLEXIS ERYTRA EFLEXIS KSZ DIAGNOSTIC GRIFOLS S.A. DG-511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown