BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POS COMBO 6.1J

    MDR report key: 1474100 · Received August 13, 2009

    Report

    Report Number
    2919016-2009-00008
    Event Type
    Malfunction
    Date Received
    August 13, 2009
    Date of Event
    July 17, 2009
    Report Date
    July 17, 2009
    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
    JA
    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: BASED ON A COMPARISON TO ANOTHER TEST METHOD, AN INCORRECT INTERPRETATION WAS PROVIDED FOR THIS ISOLATE. CONCLUSIONS: THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCREPANT RESULT. PRODUCT IS WITHIN PERFORMANCE CLAIMS. THE CAUSE OF THE (B)(6) RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED (B)(6) DISCREPANCY. THE HOSPITAL OBTAINED (B)(6) RESULTS ON THE POS COMBO 6.1J PANEL AND (B)(6) RESULTS WHEN TESTED AGAINST ANOTHER TEST METHOD ALSO PERFORMED FOR THE CLINICAL ISOLATE. RESULTS WERE NOT 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 6.1J DRIED GRAM POS PANEL LTT SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1