BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (POOLED)

    MDR report key: 2920403 · Received January 17, 2013

    Report

    Report Number
    1034569-2013-00022
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 17, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGE RESULT FILES SHOWED THAT NO ERRORS OCCURRED DURING TESTING AND THE WELL FILL VOLUME WAS ACCEPTABLE. THE RED CELL BUTTON APPEARED FUZZY WITH SLIGHT ADHERENCE IN THE WELL. THE CUSTOMER DID NOT SUBMIT ANY PRODUCT OR SAMPLE FOR INVESTIGATION. LOT N328 EXPIRED PRIOR TO THE COMPLAINT BEING RECEIVED. NO ADDITIONAL TESTING COULD BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT PRODUCT MET SPECIFICATIONS PRIOR TO DISTRIBUTION. THE CUSTOMER WAS REFERRED TO THE LIMITATION SECTION OF THE PACKAGE INSERT WHICH STATES THAT ANTIBODY SCREENING TESTS EMPLOYING POOLED REAGENT RED BLOOD CELLS WILL NOT BE AS SENSITIVE AS THOSE INCORPORATING THE RED BLOOD CELLS OF UNPOOLED SINGLE DONORS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED WITH CAPTURE-R READY-SCREEN (POOLED) TEST WELLS FOR A SAMPLE WITH A HISTORY OF HAVING ANTI-K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26706 CAPTURE-R READY-SCREEN (POOLED) REAGENT RED BLOOD CELL KSZ IMMUCOR, INC. N328

    Patients

    Seq Age Sex Outcome Treatment
    1