BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED POS COMBO TYPE 20

    MDR report key: 732970 · Received November 15, 2005

    Report

    Report Number
    2919016-2005-00038
    Event Type
    Malfunction
    Date Received
    November 15, 2005
    Date of Event
    November 9, 2005
    Report Date
    November 9, 2005
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    H6: EVALUATION: METHOD: REQUESTED CLINICAL ISOLATE FROM USER FOR EVALUATION. ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. OVERALL OXACILLIN PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. CONCLUSION: OVER OXACILLIN PERFORMANCE OF DRIED POS PANELS IS ACCEPTABLE. REQUESTED CLINICAL ISOLATE HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    SINGLE ACCOUNT REPORTED TO DADE BEHRING THAT THEY OBSERVED A CLINICAL S-AUREUS ISOLATE OXACILLIN MIC DISCREPANCY. THE ACCOUNT OBTAINED OXACILLIN SUSCEPTIBLE RESULTS ON THE DRIED POS COMBO TYPE 20 PANEL. ACCOUNT OBTAINED AN OXACILLIN-RESISTANT RESULT ON A SECONDARY METHOD (KIRBY BAUER) FOR THE CLINICAL ISOLATE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCE 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 COMBO TYPE 20 ANTIMICROBIC SUSCEPT. TEST PANELS, GRAM POSITIVE LTT DADE BEHRING, INC. NA 2006-09-16

    Patients

    Seq Age Sex Outcome Treatment
    1 *