BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY -SCREEN I AND II

    MDR report key: 2459009 · Received February 17, 2012

    Report

    Report Number
    1034569-2012-00029
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    January 18, 2012
    Report Date
    February 16, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ATTRIBUTED THE ISSUE TO THE WEAK EXPRESSION OF THE ANTI-FYA IN THE ORIGINAL SAMPLE. A DIFFERENT SAMPLE DRAWN ON THE SAME PATIENT WAS TESTED ON THE GALILEO USING THE SAME LOTS OF CAPTURE REAGENTS DETECTED THE FYA ANTIBODY. CANNOT RULE OUT SAMPLE AS THE CAUSE OF THE UNEXPECTED NEGATIVE REACTION. PI LAB CONFIRMED THE REACTIVITY OF THE FYA ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN I,II (CRRS 2), LOT X355 USING RETENTION CAPTURE-R READY INDICATOR RED CELLS (CRRIRC), LOT 221763 AND ANTI-FYA 607009 (1:8). CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. THE CUSTOMER DID NOT SUBMIT ANY PRODUCTS OR SAMPLES FOR FURTHER SEROLOGICAL INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON CAPTURE-R READY SCREEN (CRRS) I AND II ON THE GALILEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY -SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X355

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR