BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POS COMBO 26

    MDR report key: 1030929 · Received April 17, 2008

    Report

    Report Number
    2919016-2008-00006
    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
    LRG
    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

    EVAL: ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. EVAL RESULTS: REQUESTED ADDITIONAL INFO TO DETERMINE IF MALFUNCTION OCCURRED. EVAL CONCLUSIONS: PRODUCT IS WITHIN PERFORMANCE CLAIMS. THE CAUSE OF THE OXACILLIN SUSCEPTIBLE 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 POS COMBO TYPE 26 PANEL AND OXACILLIN-RESISTANT 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 POS COMBO 26 DRIED GRAM POS PANEL LRG SIEMENS HEALTHCARE DIAGNOSTICS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1