BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 800139 · Received December 21, 2006

    Report

    Report Number
    1034569-2006-00200
    Event Type
    Malfunction
    Date Received
    December 21, 2006
    Date of Event
    November 22, 2006
    Report Date
    December 21, 2006
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    bk020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION TESTING. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT. RETENTION PRODUCT WAS TESTED. THE PRESENCE OF THE D ANTIGEN ON RETENTION CRRS, LOT X159, WAS CONFIRMED WITH ANTI-D, LOT 0D547 (DILUTED 1:1500) USING RETENTION CAPTURE-R INDICATOR RED CELLS, LOT 221942. RETENTION PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE AND WEAK REACTIONS FOR A PT SAMPLE ON THE GALILEO WHEN USING CAPTURE-R READY INDICATOR CELLS, LOT 221943. THE PT HAD A HISTORY OF ANTI-FYA DETECTED. THE ANTI-FYA PRODUCED A STRONGER REACTION AND WAS DETECTED ON MULTIPLE CELLS WHEN USING CAPTURE-R READY INDICATOR CELLS, LOT 221949.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY INDICATOR CELLS ANTIGLOBULIN COATED RED BLOOD CELLS KSZ IMMUCOR * 221943

    Patients

    Seq Age Sex Outcome Treatment
    1 *