BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN

    MDR report key: 956165 · Received April 27, 2007

    Report

    Report Number
    1034569-2007-00092
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Date of Event
    April 3, 2007
    Report Date
    April 27, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMED THE PRESENCE OF THE FYA ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN (CRRS) LOT K126 AND CAPTURE-R READY-ID, LOT ID081. THE RETURNED SAMPLE WAS TESTED MANUALLY WITH RETENTION CRRS, LOT K126, THE SPECIMEN WAS QNS FOR TESTING ON THE GALILEO. THE SAMPLE WAS NEGATIVE. THE SAME SAMPLES WERE TESTED ON CAPTURE SELECT WITH PANOCELL REAGENT RED BLOOD CELLS. THE SAMPLE DEMONSTRATED WEAK POSITIVE REACTIVE WITH TWO FY(A+) CELLS. THE SAMPLE WAS QNS ANY ADD'L TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE GALILEO WHEN TESTING A PT SPECIMEN CONTAINING AN ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN REAGENT RED BLOOD CELLS KSZ IMMUCOR * K126

    Patients

    Seq Age Sex Outcome Treatment
    1 *