BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PROBETEC ET INSTRUMENT

    MDR report key: 474508 · Received July 24, 2003

    Report

    Report Number
    1119779-2003-00001
    Event Type
    Malfunction
    Date Received
    July 24, 2003
    Date of Event
    June 19, 2003
    Report Date
    July 24, 2003
    Manufacturer
    BECTON DICKINSON
    Product Code
    KHO
    Removal / Correction Number
    1119779-2002-00001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BD HAS A COMPLAINT FROM THE FIELD ABOUT ONE BD PROBETECH INSTRUMENT FROM AN ACCOUNT THAT WAS PERFORMING CT/GC TESTING. PATIENT RESULTS WERE SWITCHED FOR ROWS "F" AND "H" RESULTING IN THE POSSIBILITY OF FALSE NEGATIVE AND FALSE POSITIVE RESULTS. THE INSTRUMENT WAS RETURNED BD DIAGNOSTIC SYSTEMS AND UPON INVESTIGATION IT WAS RECOGNIZED THAT THE OPTICAL BUNDLES FOR ROWS "F" AND "H" WERE SWITCHED AT THE SOURCE/DETECTOR CONNECTION POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PROBETEC ET INSTRUMENT MOLECULAR DIAGNOSTIC TEST INSTRUMENT FOR CT/GC KHO BECTON DICKINSON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *