BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGIES PLUS POS COMBO

    MDR report key: 1030930 · Received April 17, 2008

    Report

    Report Number
    2919016-2008-00005
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 7, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LQL
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. EVALUATION RESULTS: REQUESTED ADDITIONAL INFO TO DETERMINE IF MALFUNCTION OCCURRED. EVAL CONCLUSIONS: PRODUCT IS WITHIN PERFORMANCE CLAIMS. THE CAUSE OF THE OXACILLIN SUSCEPTABLE RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED S. AUREUS ISOLATES OXACILLIN (OX) MIC DISCREPANCY. THEY OBTAINED OXACILLIN-SUSCEPTIBLE RESULTS ON THE SYNERGIES PLUS POS PANEL AND OXACILLIN-RESISTENT RESULTS ON SECONDARY METHODS THAT WERE ALSO PERFORMED FOR THE CLINICAL ISOLATE. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. NO REPORTS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCREPANT RESULT BEING OBTAINED. THE CAUSE OF THE OXACILLIN SUSCEPTIBLE RESULTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGIES PLUS POS COMBO DRIED GRAM POS PANEL LQL SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 2008-11-26

    Patients

    Seq Age Sex Outcome Treatment
    1