BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1358349 · Received April 10, 2009

    Report

    Report Number
    1034569-2009-00123
    Event Type
    Malfunction
    Date Received
    April 10, 2009
    Date of Event
    March 12, 2009
    Report Date
    April 3, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE FYA ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN (CRRS) (3), LOT R037 AND RETENTION CRRID, LOT ID 111 AND EXTEND, LOT DP033.THESE PRODUCTS WERE USED AT THE TIME OF THE EVENT. REACTIVITY OF THE K ANTIGEN WAS CONFIRMED ON RETENTION CRRS(3), LOT R037. NO K ANTIGEN CONFIRMATION WAS PERFORMED WITH RETENTION CRRID, LOT ID 111 AND EXTEND DP033 WHILE THE PRODUCT WAS IN DATE. DHR REVIEW IS ONGOING.THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING UNEXPECTED NEGATIVE REACTIONS ON THE ECHO. A PATIENT SAMPLE WAS SENT FROM ANOTHER FACILITY. IT WAS RUN ON THE ECHO AT ANOTHER FACILITY AND AN ANTI-K AND ANTI-FYA WERE IDENTIFIED.

    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