BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (4) TEST WELLS

    MDR report key: 843723 · Received February 28, 2007

    Report

    Report Number
    1034569-2007-00045
    Event Type
    Malfunction
    Date Received
    February 28, 2007
    Date of Event
    January 29, 2007
    Report Date
    February 28, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SENT SAMPLE FOR INVESTIGATION TESTING. THE SAMPLE TESTED NEGATIVE WITH RETENTION CAPTURE-R READY-SCREEN (4), LOT K118 ON AN IN-HOUSE GALILEO. THE SAMPLE WAS TESTED ALONG WITH KNOWN ANTIBODY NEGATIVE SAMPLES AND A SAMPLE KNOWN TO CONTAIN ANTI-FYA. THE KNOWN SAMPLES DEMONSTRATED THE EXPECTED REACTIONS. THE SAMPLE WAS TESTED MANUALLY WITH RETENTION CAPTURE-R READY-SCREEN (4), LOT K118 AND DEMONSTRATED VERY WEAK REACTIVITY WITH ALL FY (A+) CELLS. THE SAMPLE WAS TESTED MANUALLY WITH CAPTURE SELECT, LOT SC063 USING PANOSCREEN, LOT 49648. THE SAMPLE REACTED WITH ALL FY (A+) CELLS. THE SAMPLE WAS ALSO TESTED BY MANUAL TUBE METHOD USING PANOSCREEN, LOT 49648 AND DID NOT DEMONSTRATE REACTIVITY WITH FY(A+) CELLS. THE EVENT APPEARS TO BE DUE TO THE NATURE OF THE SAMPLE. G5: STN # 102152.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A SAMPLE FROM A PT CONTAINING A PREVIOUSLY IDENTIFIED ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (4) TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR * K118

    Patients

    Seq Age Sex Outcome Treatment
    1 *