BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1399155 · Received June 8, 2009

    Report

    Report Number
    1034569-2009-00190
    Event Type
    Malfunction
    Date Received
    June 8, 2009
    Date of Event
    May 12, 2009
    Report Date
    June 3, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE K ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY SCREEN (3), LOT R043 AND CRRID EXTEND LOT DN034, USED BY THE CUSTOMER AT THE TIME OF THE EVENT. A SERVICE CALL WAS MADE. INVESTIGATION OF CUSTOMER COMPLAINT FOUND THE INSTRUMENT TO BE OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE ECHO FOR A PATIENT SAMPLE THAT CONTAINED ANTI-K. NO TRANSFUSION REACTIONS WERE REPORTED AS A RESULT OF THIS NEGATIVE REACTION.

    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 78 YR