BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO ANTI-FYA ANTISERA

    MDR report key: 3459575 · Received November 8, 2013

    Report

    Report Number
    2250051-2013-00399
    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#FA225C BY TUBE METHOD. CUSTOMER INDICATED THAT THE UNIT WAS RETESTED WITH ANTI-FYA, LOT#FA225C AND WITH A VALIDATED METHOD USING A DILUTION OF 3% SURGISCREEN ON THE PROVUE. INCONSISTENT RESULTS WERE OBSERVED BETWEEN PROVUE AND TUBE METHOD. REACTIONS WERE ALL NEGATIVE WHEN RUN BY THE TUBE METHOD AND POSITIVE ON PROVUE. 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. CUSTOMER WAS REQUESTED TO REPEAT TESTING IN MANUAL GEL AND TO REPEAT THE TUBE METHOD TESTING BUT USING A FRESH LOT OF BLOOD BANK SALINE. CUSTOMER COMPLIED WITH THIS REQUEST AND REPORTED 1-2+ REACTIONS FOR THE DONOR AND LOT #FA225C IN MANUAL GEL, AND REPORTED 1-2+ REACTIONS WITH THE DONOR, LOT #FA225C AND A FRESH LOT OF BLOOD BANK SALINE USING THE TUBE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580476 ORTHO ANTI-FYA ANTISERA RED BLOOD CELL REAGENT KSZ ORTHO CLINICAL DIAGNOSTICS FA225C

    Patients

    Seq Age Sex Outcome Treatment
    1