BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1173743 · Received September 25, 2008

    Report

    Report Number
    1034569-2008-00467
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 22, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIVITY OF THE JKA AND FYA ANTIGENS WERE CONFIRMED ON RETENTION CRRID, LOT ID104 AND CRRS(3), LOT R027. THE CUSTOMER'S RETURNED SAMPLES ( FROM THE SAME PATIENT) WERE TESTED WITH RETENTION CRRS(3), LOT R027 ON AN IN-HOUSE ECHO. POSITIVE REACRTIVITY WAS OBSERVED WITH ONE SAMPLE ON CELL I AND CELL II; NO REACTIVITY WAS OBSERVED WITH CELL III. STRONG REACTIVITY WAS OBSERVED WITH THE OTHER SAMPLE ON CELLS I, II AND III. THE CUSTOMER'S SAMPLES WERE ALSO TESTED WITH RETENTION CRRID, LOT ID104 ON AN IN-HOUSE ECHO. AN INVALID INTERPRETATION WAS OBSERVED WITH 1 SAMPLE. THE OTHER SAMPLE GAVE A POSITIVE INTERPRETATION IN 9 OF 14 REAGENT RED CELLS, 3 EQUIVOCALS [ONE EQUIVOCAL WAS AN FY(A-); JK(A+B+) REAGENT RED CELL]AND 2 NEGATIVE RESULTS. A SERVICE CALL WAS MADE. THE ISSUE OF UNEXPECTED NEGATIVE REACTION FOR CRRID COULD NOT BE DUPLICATED. REPLACED THE CAMERA MODULE AS A PREVENTATIVE ACTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTION WITH CAPTURE-R READY ID (CRRID) ON THE ECHO. THE PATIENT SAMPLE HAD A HISTORY OF ANTI-JK(A) AND ANTI-FY(A). ANTI-JK(A) WAS DETECTED ON THE ECHO, BUT THE ANTI-FY(A) WAS NOT DETECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR