BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 3244398 · Received July 24, 2013

    Report

    Report Number
    1034569-2013-00130
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 24, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REPEAT TESTING USING A DIFFERENT VIAL (SAME LOT) OF INDICATOR CELLS, THE CUSTOMER OBTAINED THE EXPECTED POSITIVE RESULTS. IN-HOUSE TESTING CONFIRMED THE REACTIVITY OF LOT 221003. UNABLE TO RULE OUT THAT INITIAL VIAL OF THE CUSTOMERS INDICATOR CELLS HAD BECOME COMPROMISED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED DURING COMPATIBILITY TESTING ON GALILEO ECHO M01133.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345216 CAPTURE-R READY INDICATOR CELLS ANTIGLOBULIN COATED RED BLOOD CELLS KSZ IMMUCOR, INC. 221003

    Patients

    Seq Age Sex Outcome Treatment
    1