BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED POS MIC PANEL TYPE 20A

    MDR report key: 761927 · Received November 9, 2005

    Report

    Report Number
    2919016-2005-00032
    Event Type
    Malfunction
    Date Received
    November 9, 2005
    Date of Event
    October 13, 2005
    Report Date
    October 13, 2005
    Manufacturer
    DADE BEHRING INC.
    Product Code
    LTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED CLINICAL ISOLATE FROM USER FOR EVALUATION. ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. EVAL CODES: CONCLUSIONS; OVERALL OXACILLIN PERFORMANCE OF DRIED POS PANELS IS ACCEPTABLE.

    Description of Event or Problem · 1

    SINGLE ACCOUNT REPORTED TO DADE BEHRING THAT THEY OBSERVED A CLINICAL S. AUREOUS ISOLATE OXACILLIN MIC DISCREPANCY. THE ACCOUNT OBTAINED OXACILLIN-SUSCEPTIBLE RESULTS ON THE DRIED POS MIC PANEL TYPE 20A PANEL AND OXACILLIN-RESISTANT RESULTS ON A SECONDARY METHOD MRSA SCREEN AGAR) FOR THE CLINICAL ISOLATE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES TO THE PT AS A RESULT OF THE FALSE SUSCEPTIBLE RESULTS BEING OBTAINED. CLINICAL ISOLATE NO LONGER AVAILABLE TO BE SUBMITTED BY THE ACCOUNT FOR TESTING BY DADE BEHRING.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other