BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE #1- DRIED NEG BP COMBO TYPE 30

    MDR report key: 2982224 · Received November 1, 2005

    Report

    Report Number
    2919016-2005-00031
    Event Type
    Malfunction
    Date Received
    November 1, 2005
    Date of Event
    July 25, 2005
    Report Date
    October 3, 2005
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LON
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - TESTED ISOLATE ON MULTIPLE PANEL TYPES, WITH MULTIPLE INOCULATION METHODS. TESTED D-12 SPECIMEN ON FROZEN REFERENCE PANELS. ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. RESULTS - IN HOUSE TESTING OF D-12 SPECIMEN YIELDED (B)(4). COMPLAINT REVIEW INDICATES PRODUCT IS PERFORMING AS EXPECTED. CONCLUSION - IN HOUSE TESTING OF D-12 SPECIMEN PROVIDED (B)(4). OVERALL PRODUCT PERFORMANCE IS ACCEPTABLE.

    Description of Event or Problem · 1

    DADE BEHRING PARTICIPATED IN THE (B)(4) AND OBTAINED LOWERED MICS FOR S. MALTOPHILIA D-12 SPECIMEN FOR CEFTAZIDIME IN INTERNAL TESTING. S. MALTOPHILIA YIELDED FALSE SUSCEPTIBLE RESULTS FOR CEFTAZIDIME (CAZ) WHEN COMPARED TO FROZEN REFERENCE PANELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE #1- DRIED NEG BP COMBO TYPE 30 ANTIMICROBIAL SUSCEPT. TEST PANEL: DRIED NEG LON DADE BEHRING, INC. NA 2006-06-29

    Patients

    Seq Age Sex Outcome Treatment
    1