BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POS COMBO 26

    MDR report key: 1194717 · Received October 3, 2008

    Report

    Report Number
    2919016-2008-00011
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. RESULTS: TESTING PERFORMED BY A REFERENCE LAB CONFIRMED DISCREPANT RESULTS. CONCLUSIONS: PRODUCT IS WITHIN PERFORMANCE CLAIMS. THE CAUSE OF THE OXACILLIN SUSCEPTIBLE RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED (B) (6) DISCREPANCY. THEY OBTAINED (B) (6) RESULTS ON THE POS COMBO 26 PANEL AND (B) (6) RESULTS WHEN TESTED AGAINST ANOTHER TEST METHOD ALSO PERFORMED FOR THE CLINICAL ISOLATE. IT IS UNKNOWN IF THE RESULTS WERE REPORTED TO THE PHYSICIAN. TREATMENT WAS NOT DELAYED OR WITHHELD. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCREPANT RESULT.

    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 2009-02-08

    Patients

    Seq Age Sex Outcome Treatment
    1