BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 3085526 · Received April 30, 2013

    Report

    Report Number
    1034569-2013-00069
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 30, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REPEAT TESTING USING A DIFFERENT LOT OF INDICATOR CELLS, THE CUSTOMER OBTAINED THE EXPECTED POSITIVE RESULTS. UNABLE TO RULE OUT THAT INITIAL VIAL OF INDICATOR CELLS HAD BECOME COMPROMISED. ADDITIONAL INVESTIGATION COULD NOT BE PERFORMED DUE TO THE INITIAL LOT, 221947, EXPIRING ON 11APR2013. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER STATED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED WHEN TESTING A PATIENT SAMPLE WITH A HISTORY OF HAVING ANTI-E AND A POSSIBLE ANTI-JKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185980 CAPTURE-R READY INDICATOR CELLS RED BLOOD CELLS KSZ IMMUCOR, INC. 221947

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR