BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON H PYLORI (P) KIT

    MDR report key: 2067677 · Received April 25, 2011

    Report

    Report Number
    2518658-2011-00008
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LYR
    PMA / PMN Number
    K980798
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION BY (B)(4) WITH RETAIN AND RETURN DEVICES USING CONTROLS AND CONFIRMED POSITIVE CALIBRATORS EXHIBITED EXPECTED RESULTS. NO PATIENT SAMPLE WAS AVAILABLE FOR INVESTIGATION. COMPLAINT NOT CONFIRMED, AS DEVICES PERFORM AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE ICON H PYLORI (P) TEST WAS GENERATING DISCREPANT RESULTS, WHERE THE WHOLE BLOOD TESTED NEGATIVE AND THE SERUM WAS TESTED POSITIVE. TESTS WERE REPEATED AND GAVE POSITIVE RESULTS AS EXPECTED. NO PATIENT SAMPLE INFORMATION WAS SUPPLIED. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON H PYLORI (P) KIT H PYLORI (P) KIT LYR BECKMAN COULTER INC. ICON HP 240D11

    Patients

    Seq Age Sex Outcome Treatment
    1