BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1112923 · Received August 15, 2008

    Report

    Report Number
    1034569-2008-00321
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 11, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANTI-E, LOT 6G619-1 DIL 1:128 AND A RETURNED PATIENT SAMPLE (HISTORY OF ANTI-E & -C) WERE TESTED ON AN IN-HOUSE ECHO USING FRESH STRIP OF CRRS(3), LOT R023. THE TEST WAS REPEATED USING THE BALANCE STRIP THAT WAS USED ON THE INITIAL TESTING. THE PATIENT SAMPLE WAS NONREACTIVE. THE ANTI-E EXHIBITED POSITIVE REACTIVITY WITH THE FRESH AND THE BALANCE STRIP OF CRRS(3), LOT R023. THE RETURNED PATIENT SAMPLES WERE TESTED ON AN IN-HOUSE ECHO AND EXHIBITED POSITIVE REACTIVITY WITH FRESH STRIPS OF RETENTION CRRS(3), LOT R023. TWO OF THREE RETURNED SAMPLES (THAT EXHIBITED STRONGER REACTIVITY) WERE RETESTED ON THE ECHO USING THE BALANCE STRIP; NEGATIVE REACTIVITY WAS OBSERVED. THE CUSTOMER'S OBSERVATION WAS REPRODUCED. THE RETURNED SAMPLE WAS TESTED IN HEMAGGLUTINATION TESTS WITH CELL II FROM RETENTION PANOSCREEN I, II AND III, LOT 26810, USING IMMUADD AS THE POTENTIATOR. REACTIVITY (2+) WAS OBSERVED AT THE INDIRECT ANTIGLOBULIN TEST PHASE. QC AND IN-HOUSE DONOR TESTING WERE PERFORMED USING RETENTION CRRS(3), LOT R025. PRIOR TO TESTING, THE BALANCE STRIP WAS EXAMINED AND WELLS APPEARED AS EXPECTED. THE BALANCE STRIP EXHIBITED WHITE RESIDUE ON THE BOTTOM OF THE WELLS AFTER THE QC RUN. NO PROBLEMS WERE OBSERVED IN THE DHR REVIEW OF CRRS 3 LOT R023. IN A COMMUNICATION SENT OUT 8/15/08, CUSTOMERS WERE NOTIFIED NOT TO USE ANY CAPTURE-R READY SCREEN ASSAY BALANCE STRIPS FOR PATIENT TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING WITH CAPTURE-R READY SCREEN (CRRS)3 STRIPS ON THE ECHO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1