BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 1063153 · Received June 24, 2008

    Report

    Report Number
    1034569-2008-00207
    Event Type
    Malfunction
    Date Received
    June 24, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 23, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE C ANTIGEN WAS CONFIRMED ON RETENTION CRRID, LOT ID097. AB_ID ASSAY WAS PERFORMED ON AN IN-HOUSE GALILEO WITH CUSTOMER'S RETURNED SAMPLE USING RETENTION CAPTURE-R READY-ID, LOT ID097. THE SAMPLE EXHIBITED 3+ TO 4+ REACTIVITY WITH ALL D+ AND D+C+ CELLS. HA WAS PERFORMED WITH CUSTOMER'S RETURNED SAMPLE USING SELECTED C+ CELLS FROM RETENTION PANOCELL-20, LOT 04478. IMMUADD WAS USED AS THE POTENTIATOR. TESTING WAS PERFORMED AT IS,15'RT, 15'37C, AND IAT. SAMPLE WAS NONREACTIVE WITH ALL CELLS AT IS, EXHIBITED WEAK REACTIVITY WITH D+C+ CELLS AND NEGATIVE TO VERY WEAK REACTIVITY WITH D-C+C+ CELLS AT 15'RT, WEAK TO MODERATE REACTIVITY WITH D+C+ CELLS AND VERY WEAK REACTIVITY WITH D-C+C+ CELLS AT 15'37C. AT IAT, SAMPLE EXHIBITED 3+ TO 3+S REACTIVITY WITH D+C+ CELLS AND MICROSCOPIC TO VERY WEAK REACTIVITY WITH D-C+C+ CELLS. SAMPLE WAS NONREACTIVE WITH D-C- CELL IN ALL TESTING. THE PACKAGE INSERT STATES "NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SERUM CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED." ALSO, "SPECIFICITIES OF PRESUMED SIGNIFICANCE, THAT ARE WHOLLY IGM IN NATURE (IE, IGM ANTI-K OR IGM ANTI-E) MAY FAIL TO REACT IN THIS ASSAY."

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON GALILEO USING CAPTURE-R READY-ID (CRRID). A PATIENT SAMPLE CAME UP POSITIVE FOR ANTI-D ON ABID ASSAY. WHEN TESTED WITH GEL METHOD, ANTI-C WAS IDENTIFIED ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. ID097

    Patients

    Seq Age Sex Outcome Treatment
    1