BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA

    MDR report key: 19476742 · Received June 6, 2024

    Report

    Report Number
    3002772505-2024-00002
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 6, 2024
    Manufacturer
    DIAGNOSTIC GRIFOLS S.A.
    Product Code
    KSZ
    PMA / PMN Number
    BK170130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THE AFFECTED LOT OF DG GEL ANTI-IGG LOT: 23016.01 WAS PERFORMED. IT WAS CONFIRMED THAT NO INCIDENTS WERE REPORTED DURING THE PRODUCTION PROCESS OF THIS LOT THAT COULD HAVE CAUSED THE REPORTED EVENT. LIKEWISE, QUALITY CONTROL (QC) RECORD FOR THE MENTIONED DG GEL ANTI-IGG LOT: 23016.01 DOES NOT SHOW INCIDENTS AND ALL TESTS PERFORMED MET THE ACCEPTANCE CRITERIA (SPECIFICITY FOR POSITIVE AND NEGATIVE SAMPLES AND POTENCY TEST) SPECIFICALLY FOR DAT AND IAT. AFTER A VISUAL INSPECTION OF THE MICROTUBE AND RAW IMAGE OF WELL 8 OF CARD 714111240160122489 IN WHICH THE CROSSMATCH TEST WAS PERFORMED, 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 IMAGES PROVIDED HAS BEEN CARRIED OUT AND THE ADJUSTMENT PARAMETERS OF THE READER OF THE IMPLICATED ERYTHRA DO NOT SHOW ANY ANOMALY. THE ADJUSTMENT PARAMETER VALUES SUCH AS ILLUMINATION LEVEL, WHITE BALANCE FACTORS AND CONVERSION FACTOR ARE AS EXPECTED. THE OBTAINED RESULT IS AS EXPECTED BASED ON CURRENT VISION ALGORITHMS AND, ACCORDING TO THE VALIDATED CRITERIA IMPLEMENTED IN ERYTHRA SOFTWARE VERSION 4.2.0, THE MICROTUBE IS CONSIDERED CORRECTLY CLASSIFIED AS NEGATIVE. SINCE NOT ENOUGH POINTS HAVE BEEN DETECTED TO CONSIDER THIS REACTION AS "+/-". FOR THIS REASON, THE IMAGE HAS BEEN CLASSIFIED AS NEGATIVE BY THE INSTRUMENT. 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. 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 SYSTEM SENSITIVITY AND ARE NOT DEEMED TO CAUSE SERIOUS TRANSFUSION REACTIONS OR DEATH IF THE REACTION WERE SPECIFIC AND A POTENTIALLY INCORRECT BLOOD PRODUCT WERE TRANSFUSED. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBTENTION OF AN UNEXPECTED NEGATIVE RESULT IN A CROSSMATCH TEST WITH DG GEL ANTI-IGG CARD, LOT 23016.01 IN ERYTHRA INSTRUMENT WITH SOFTWARE VERSION 4.2.0. HOWEVER, ON VISUAL OBSERVATION OF THE RESULTS, WEAK AGGLUTINATION WAS PRESENT. THE IMPLICATED BLOOD BAG UNIT WAS ISSUED AND TRANSFUSED TO A DIFFERENT PATIENT WITHOUT ANY REPEAT TESTING OR MANUAL INVESTIGATIONS. THEREFORE, PATIENT SAFETY WAS NOT IMPAIRED. HOWEVER, AS THERE HAVE BEEN PREVIOUS CASES IN WHICH THIS TYPE OF FAILURE MODE HAS CAUSED A TRANSFUSION REACTION IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861945 ERYTRA ERYTRA KSZ DIAGNOSTIC GRIFOLS S.A. DG-059 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown