BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSITITRE

    MDR report key: 2006264 · Received February 25, 2011

    Report

    Report Number
    MW5019597
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 25, 2011
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS LTD.
    Product Code
    NGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TREK YEASTONE MIC PANEL WAS MODIFIED BY THE MANUFACTURER IN (B)(6) 2010 AND THE COMPANY FAILED TO NOTIFY US. APPLYING THE OLD PLATE WELL CONFIGURATION TO READING THE NEW PLATE WELL FORMAT WILL RESULT IN EITHER FALSELY LOWER OR HIGHER FLUCONAZOLE MICS BY ONE DILUTION, DUE TO THE RECONFIGURATION OF THE PLATE WELLS. THIS ERROR HAS THE POTENTIAL OF REPORTING FALSE FLUCONAZOLE SUSCEPTIBILITY, AND MAY LEAD TO INCORRECT ANTIFUNGAL THERAPY. DATES OF USE: (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: CANDIDEMIA - CANDIDA TROPICALIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSITITRE YEASTONE NGZ TREK DIAGNOSTIC SYSTEMS LTD. B0382

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR