BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN TEST WELLS

    MDR report key: 1032751 · Received April 24, 2008

    Report

    Report Number
    1034569-2008-00117
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 16, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACTIVITY OF THE D ANTIGEN WAS CONFIRMED ON CAPTURE-R READY-SCREEN, LOT K170.THE CUSTOMER SENT ONE PATIENT SAMPLE FOR INVESTIGATION TESTING. THE SAMPLE WAS TESTED ON AN IN-HOUSE GALILEO WITH RETENTION CRRS 4, LOT K170 AND USING RETURNED INDICATOR CELLS. THE CUSTOMER?S SAMPLE SHOWED POSITIVE REACTIONS WITH THE D+ CELLS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MISSED ANTIBODIES ON 2 PATIENT SAMPLES TESTED ON GALILEO USING CAPTURE-R READY SCREEN LOT K170. THE SAME PATIENT SAMPLES WERE TESTED ON THE ECHO AND POSITIVE RESULTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. K170

    Patients

    Seq Age Sex Outcome Treatment
    1