BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR CELLS

    MDR report key: 3012827 · Received March 20, 2013

    Report

    Report Number
    1034569-2013-00050
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE RESULT FILES FOR INITIAL TESTING PERFORMED ON (B)(6) 2013, SHOWED THAT RESULTS VISUALLY APPEARED AS REPORTED BY THE INSTRUMENT. REPEAT TESTING ON (B)(6) 2013 SHOWED THAT POSITIVE RESULTS WERE OBTAINED AS EXPECTED WHEN USING A DIFFERENT LOT OF INDICATOR CELLS DUE TO LOT 221929 EXPIRING ON 21FEB2013. CONTROLS REACTED AS EXPECTED. THE INITIAL LOT OF INDICATOR CELLS EXPIRED PRIOR TO RECEIPT OF THE COMPLAINT. WE WERE UNABLE TO RULE OUT THAT THE INITIAL VIAL OF INDICATOR CELLS HAD BEEN COMPROMISED. 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-D AND ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114804 CAPTURE-R READY INDICATOR CELLS RED BLOOD CELLS KSZ IMMUCOR, INC. 221929

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR