BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO ANTI-FYA ANTISERA

    MDR report key: 3459377 · Received November 8, 2013

    Report

    Report Number
    2250051-2013-00395
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    October 22, 2013
    Report Date
    November 8, 2013
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW AND COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT AVAILABLE TO BE SENT TO OCD FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH A DONOR # (B)(6) AND FYA ANTIGEN TYPING PERFORMED WITH THE ORTHO ANTI-FYA LOT#FA225B. INITIAL TESTING WAS PERFORMED ON (B)(6) 2013 AND RESULTS WERE REPORTED AS NEGATIVE FOR THE FYA ANTIGEN BY TUBE METHOD. CUSTOMER STATED THAT THE TESTING WAS REPEATED USING THE SAME ANTI-FYA, LOT#FA225B ON PROVUE, BY A VALIDATED METHOD USING A DILUTION OF 3% SURGISCREEN, WHICH RESULTED IN A 1- 2+ REACTION FOR THE FYA ANTIGEN FOR THE UNIT. CUSTOMER INDICATED THAT THE UNIT WAS RETESTED THREE TIMES BETWEEN THE SAME LOT AND 2 DIFFERENT LOTS OF ANTI-FYA, LOT#FA225C AND LOT#FA226C; INCONSISTENT RESULTS WERE OBSERVED BETWEEN PROVUE AND TUBE METHOD. REACTIONS WERE ALL NEGATIVE WHEN RUN BY THE TUBE METHOD. CUSTOMER STATED THAT NO INCORRECT OR ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THE REPORTED CONCERN. THE UNITS WERE NOT TRANSFUSED TO A PATIENT WITH ANTI-FYA. QUALITY CONTROLS WERE CONFIRMED TO BE ACCEPTABLE WITH ORTHO HETEROZYGOUS DONORS ON THE DAY OF USE. ALL REAGENTS AND CARDS WERE CONFIRMED TO HAVE BEEN STORED AS PER THE IFU AND VISUAL APPEARANCE BEFORE USE WAS ACCEPTABLE. AS PART OF TROUBLESHOOTING THE CUSTOMER WAS REQUESTED TO RETEST THE DONOR UNIT IN MANUAL GEL USING ANTI-FYA LOT#FA225B; THE DONOR HAD A 1-2+ REACTIONS. ALSO AS PART OF TROUBLESHOOTING THE CUSTOMER WAS REQUESTED TO CHANGE TO A FRESH CONTAINER OF BLOOD BANK SALINE FOR THE TUBE METHOD; THIS TESTING GAVE 1-2+ REACTIONS WITH THE SAME LOT OF ANTI-FYA WITH THE DONOR UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580131 ORTHO ANTI-FYA ANTISERA RED BLOOD CELL REAGENT KSZ ORTHO CLINICAL DIAGNOSTICS FA225B

    Patients

    Seq Age Sex Outcome Treatment
    1