BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED GRAM POSITIVE MIC 26

    MDR report key: 1920706 · Received October 28, 2010

    Report

    Report Number
    2919016-2010-00013
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LQM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. EVAL RESULTS: BASED ON COMPARISON TO ANOTHER TEST METHOD, AN INCORRECT INTERPRETATION WAS PROVIDED FOR THIS ISOLATE. EVAL CONCLUSIONS: THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCREPANT RESULT. PRODUCT IS WITHIN PERFORMANCE CLAIMS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED (B)(6) DISCREPANCY. THE HOSP OBTAINED (B)(6) RESULTS ON THE PANEL AND (B)(6) RESULTS WHEN TESTED AGAINST ANOTHER TEST METHOD FOR THE ISOLATE. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. RESULTS WERE 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 DRIED GRAM POSITIVE MIC 26 DRIED GRAM NEGATIVE PANEL TYPE LQM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1