BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE #4- SYNERGIES PLUS NC2

    MDR report key: 2982223 · Received November 1, 2005

    Report

    Report Number
    2919016-2005-00043
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD ¿ OTHER- 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- OTHER- IN-HOUSE TESTING OF D-12 SPECIMEN YIELDED FALSE SUSCEPTIBLE RESULTS WHEN COMPARED TO FROZEN REFERENCE PANELS. COMPLAINT REVIEW INDICATES PRODUCT IS PERFORMING AS EXPECTED. CONCLUSION- OTHER ¿ UNUSUAL EVENT ¿ IN HOUSE TESTING OF D-12 SPECIMEN PROVIDED FALSE SUSCEPTIBLE RESULTS WHEN COMPARED TO FROZEN REFERENCE PANELS. OVERALL PRODUCT PERFORMANCE IS ACCEPTABLE. DEVICE 4 OF 4. REFERENCE MFR REPORT NUMBERS: 2919016-2005-0031, 00041, 0042.

    Description of Event or Problem · 1

    DADE BEHRING PARTICIPATED IN THE 2005 CAP BACTERIOLOGY SURVEY D 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 #4- SYNERGIES PLUS NC2 ANTIMICROBIAL SUSCEPT. TEST PANEL: DRIED NEG LON DADE BEHRING, INC. NA 2005-09-24

    Patients

    Seq Age Sex Outcome Treatment
    1