BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-CMV INDICATOR RED CELLS

    MDR report key: 2096609 · Received May 19, 2011

    Report

    Report Number
    1034569-2011-00057
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    LJO
    PMA / PMN Number
    K910003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A MARKET WITHDRAWAL REGARDING CAPTURE-CMV INDICATOR RED CELLS LOT 228143, EXP 2011-04-29, WAS RELEASED TO CUSTOMERS ON 11APR2011. THE MARKET WITHDRAWAL WAS ISSUED TO COVER THE WEAKER REACTIVITY THAT THE LOT WAS DEMONSTRATING. NO CONFIRMATORY TESTING WAS PERFORMED TO DETERMINE WHETHER RESULTS INITIAL RESULTS OR REPEAT TESTING RESULTS ARE CORRECT. NO SAMPLES WERE RETURNED TO MANUFACTURER FOR SEROLOGICAL TESTING. IMMUCOR HAS MADE SEVERAL ATTEMPTS TO RETRIEVE IMAGES AND SAMPLES; HOWEVER, CUSTOMER IS UNABLE TO PROVIDE THE REQUESTED FILE IMAGES OR ADDITIONAL SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CAPTURE-CMV ON THE GALILEO. WHEN RE-TESTING SAMPLES, THEY FOUND THAT 6 PREVIOUSLY NEGATIVE RESULTS RESULTED POSITIVE WHEN TESTED WITH A NEW LOT NUMBER OF CAPTURE-CMV INDICATOR RED CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-CMV INDICATOR RED CELLS ANTI-IGG COATED INDICATOR RED CELLS FOR USE IN SOLID PHASE ASSAYS LJO IMMUCOR, INC. 228143

    Patients

    Seq Age Sex Outcome Treatment
    1