BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1327708 · Received March 3, 2009

    Report

    Report Number
    1034569-2009-00052
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    February 3, 2009
    Report Date
    February 25, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF E, C AND K ANTIGENS WAS CONFIRMED ON RETENTION CRRS(3), LOT R034. THIS PRODUCT WAS USED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENING RESULTS ON ECHO. DURING VALIDATION, WHEN TESTING A PATIENT SAMPLE WITH A HISTORY OF ANTI-E, -K, AND -C WITH ONLY THE ANTI-K BEING DEMONSTRABLE, A NEGATIVE ANTIBODY SCREEN RESULT WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR

    Patients

    Seq Age Sex Outcome Treatment
    1