BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED POS MIC TYPE 20A

    MDR report key: 1002088 · Received February 20, 2008

    Report

    Report Number
    2919016-2008-00003
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 12, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LTT
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, - ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. EVALUATION RESULTS - REQUESTED ADDITIONAL INFORMATION TO DETERMINE IF MALFUNCTION OCCURRED. EVALUATION CONCLUSIONS - PRODUCT IS WITHIN PERFORMANCE CLAIMS. THE CAUSE OF THE OXACILLIN SUSCEPTIBLE RESULTS IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED S AUREUS ISOLATES OXACILLIN (OX) MIC DISCREPANCY. THEY OBTAINED OXACILLIN-SUSCEPTIBLE RESULTS ON THE DRIED POS MIC TYPE 20A PANEL AND OXACILLIN-RESISTANT RESULTS ON SECONDARY METHODS THAT WERE ALSO PERFORMED FOR THE CLINICAL ISOLATE. IT IS UNK IF THE RESULTS WERE 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 UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIED POS MIC TYPE 20A ANTIMICROBIC SUSCEPT. PANEL: GRAM POS LTT SIEMENS HEALTHCARE DIAGNOSTICS INC NA 2008-11-06

    Patients

    Seq Age Sex Outcome Treatment
    1