BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (POOLED CELLS)

    MDR report key: 956394 · Received April 27, 2007

    Report

    Report Number
    1034569-2007-00083
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Date of Event
    April 4, 2007
    Report Date
    April 27, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMED THE PRESENCE OF E ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN (POOLED CELLS), LOT N109. THE USE OF POOLED REAGENT RED BLOOD CELLS FOR ANTIBODY DETECTION IS WELL DOCUMENTED IN LITERATURE AS LESS SENSITIVE THAN TEST METHODS USING UNPOOLED, SINGLE DONOR RED CELLS. THE PACKAGE INSERT FOR CAPTURE-R READY-SCREEN (POOLED CELLS) STATES: "ANTIBODY SCREENING TESTS EMPLOYING POOLED REAGENT RED CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORATING THE RED CELLS OF UNPOOLED SINGLE DONORS. POOLED REAGENT RED CELLS SHOULD NOT BE USED WHEN THE ANTIGLOBULIN CROSSMATCH." AND "NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SPECIMEN CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED."

    Description of Event or Problem · 1

    CUSTOMER IS REPORTED THAT THE GALILEO POOL ASSAY DID NOT DETECT ANTI-E DONOR UNITS CAPTURE-R READY-SCREEN (POOLED CELLS). CUSTOMER EXPLAINED THAT SEVERAL OF THESE UNITS ASSOCIATED WITH THE COMPLAINT WERE AUTOLOGOUS DONORS WHERE THE ANTI-E WAS DETECTED DURING THE PRE-SURGERY WORK UP USING MORE SENSITIVE ANTIBODY DETECTION TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (POOLED CELLS) REAGENT RED BLOOD CELLS KSZ IMMUCOR * N109

    Patients

    Seq Age Sex Outcome Treatment
    1