BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED POS MIC PANEL TYPE 20A

    MDR report key: 738069 · Received July 6, 2006

    Report

    Report Number
    2919016-2006-00009
    Event Type
    Malfunction
    Date Received
    July 6, 2006
    Date of Event
    June 15, 2006
    Report Date
    June 15, 2006
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACTED CUSTOMER TO OBTAIN CLINICAL ISOLATE FOR EVALUATION. ROUTINE MONITORING OF COMPLAIN HISTORY, AND PERFOMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. CLINICAL ISOLATE HAS NOT BEEN RECEIVED FROM THE CUSTOMER. INHOUSE TESTING OF THE ISOLATE IS ANTICIPATED, BUT NOT YET PERFORMED. OVERALL OXACILLIN PERFORMANCE OF DRIED POS PANELS IS ACCEPTABLE.

    Description of Event or Problem · 1

    SINGLE ACCOUNT REPORTED TO DADE BEHRING THAT THEY OSBERVED A CLINICAL S.AUREUS ISOLATE OXACILLIN MIC DISCREPANCY. THE ACCOUNT OBTAINED OXACILLIN-SUSCEPTIBLE RESULTS ON THE DRIED POS MIC PANEL TYPE 20A PANEL AND OXACILLILN-RESISTANCT RESULTS ON A SECONDARY METHOD (CEFOXITIN DOSK SCREEN) ALSO PERFORMED FOR THE CLINICAL ISOLATE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THE FALSE SUSCEPTIBLE RESULTS BEING OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIED POS MIC PANEL TYPE 20A ANTIMICROBIC SUSCEPT. TEST PANELS: GRAM POS. LTT DADE BEHRING, INC. NA 20007-04-06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN UNK.
    2 NA.