BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED POS COMBO TYPE 21

    MDR report key: 761922 · Received November 9, 2005

    Report

    Report Number
    2919016-2005-00033
    Event Type
    Malfunction
    Date Received
    November 9, 2005
    Date of Event
    October 14, 2005
    Report Date
    October 14, 2005
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED CLINICAL ISOLATE FROM USER FOR EVAL. ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. EVAL: CONCLUSIONS; OTHER - 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 COMBO TYPE 21 PANEL AND OXACILLIN-RESISTANT RESULTS ON A SECONDARY METHOD OXACILLIN SCREEN AGAR) FOR THE CLINICAL ISOLATE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES TO THE PT AS A RESULT OF THE FALSE SUSEPTIBLE RESULTS BEING OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIED POS COMBO TYPE 21 ANTIMICROBIC SUSCEPT. TEST PANELS: GRAM POS. LTT DADE BEHRING, INC. NA 2006-07-27

    Patients

    Seq Age Sex Outcome Treatment
    1 Other