BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-CMV INDICATOR RED CELLS

    MDR report key: 2143271 · Received June 28, 2011

    Report

    Report Number
    1034569-2011-00078
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 24, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    LJO
    PMA / PMN Number
    K910003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMED A CMV ASSAY ON 24 KNOWN NEGATIVE CMV DONORS ON THE GALILEO USING ONE FULL PLATE OF RETENTION CAPTURE-CMV, LOT (B)(4) AND CAPTURE-CMV INDICATOR RED CELLS, LOT (B)(4). CONTROLS PERFORMED AS EXPECTED AND 22 OF THE DONORS TESTED NEGATIVE AS EXPECTED. TWO OF THE DONORS REPEATEDLY TESTED POSITIVE (X3). THOSE DONORS TESTED CMV NEGATIVE USING CAPTURE-CMV INDICATOR RED CELLS, (B)(4). RETENTION PRODUCTS DID NOT PERFORM AS EXPECTED. PERFORMED A CMV ASSAY ON 6 KNOWN CMV NEGATIVE IN HOUSE DONORS ON THE GALILEO USING RETENTION CAPTURE-CMV, LOT (B)(4) AND THE CUSTOMERS RETURNED VIALS OF CAPTURE-CMV INDICATOR RED CELLS, LOT (B)(4). CONTROLS PERFORMED AS EXPECTED AND ALL IN HOUSE DONORS TESTED NEGATIVE AS EXPECTED WITH THE FIRST VIAL TESTED. ONE OF THE 6 DONORS TESTED POSITIVE WHEN USING THE SECOND VIAL. RETURNED PRODUCTS DID NOT PERFORM AS EXPECTED. PERFORMED A CMV ASSAY ON THE CUSTOMERS RETURNED SAMPLES ON THE GALILEO USING RETENTION CAPTURE-CMV, LOT C087 AND CAPTURE-CMV INDICATOR RED CELLS, LOT (B)(4). CONTROLS PERFORMED AS EXPECTED AND ONLY SAMPLE (B)(6) TESTED NEGATIVE. ALL FOUR SAMPLES TESTED POSITIVE. A SERVICE CALL WAS MADE. ADJUSTMENTS MADE TO THE INSTRUMENT AS NEEDED. TESTED CMV NEGATIVE PATIENT SAMPLES, 7/9 SAMPLES CAME OUT WEAK POSITIVE. INSTRUMENT IS WORKING WITHIN SPECIFICATIONS MECHANICALLY. CANNOT RULE OUT THAT THE CMV INDICATOR CELLS MAY HAVE BEEN COMPROMISED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DONORS SAMPLES THAT WERE PREVIOUSLY REPORTED OUT AS CMV NEGATIVE ARE NOW DISPLAYING POSITIVE REACTIVITY ON THE GALILEO. THE CUSTOMER STATED NO REPEAT TESTING ON THE INSTRUMENT WAS DONE OR WILL BE PERFORMED. THE CUSTOMER STATED NO ADVERSE EVENT OCCURRED AS A RESULT OF THE UNEXPECTED REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-CMV INDICATOR RED CELLS ANTI-IGG AND ANTI-IGM COATED RED CELLS INTENDED FOR USE IN CAPTURE-CMV ASSAYS LJO IMMUCOR, INC. 228149

    Patients

    Seq Age Sex Outcome Treatment
    1