BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCAN DRIED POS MIC PANEL TYPE 20A

    MDR report key: 626170 · Received August 1, 2005

    Report

    Report Number
    2919016-2005-00006
    Event Type
    Malfunction
    Date Received
    August 1, 2005
    Date of Event
    March 23, 2005
    Report Date
    July 28, 2005
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SINGLE ACCOUNT REPORTED TO DADE BEHRING A CLINICAL S. AUREUS ISOLATE OXACILLIN MIC DISCREPANCY. THE ACCOUNT OBTAINED AN OXACILLIN SUSCEPTIBLE RESULT ON THE MICROSCAN DRIED POS MIC PANEL TYPE 20A LOT#2006-02-04 PANEL AND AN OXACILLIN RESISTANT RESULT ON A SECONDARY METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSCAN DRIED POS MIC PANEL TYPE 20A ANTIMICROBIC SUSCEPT. TEST PANELS: GRAM POS. LTT DADE BEHRING, INC. NA 2006-02-04

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other