BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON DS STREP A

    MDR report key: 2094424 · Received May 18, 2011

    Report

    Report Number
    2518658-2011-00009
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GTY
    PMA / PMN Number
    K010582
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS THROAT SWAB. RETAIN DEVICES TESTED BY BCI USING CONTROLS AND LOW, MEDIUM, AND HIGH CALIBRATORS PRODUCED EXPECTED RESULTS. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. THE CUSTOMER WILL RETURN THE KIT BOX FOR INVESTIGATION. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO (B)(6) SWAB (-) RESULTS OBTAINED FROM ICON DS STREP A FOR TWELVE PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE TWELVE PATIENTS WERE (B)(6) ON CULTURES. THERE WAS NO REPORT OF DEATH OR INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON DS STREP A STREP A TEST GTY BECKMAN COULTER, INC. NA 420M21

    Patients

    Seq Age Sex Outcome Treatment
    1