BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSITIVE COMBO 20

    MDR report key: 1851077 · Received September 29, 2010

    Report

    Report Number
    2919016-2010-00012
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LQL
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD- ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. RESULTS: OTHER - BASED ON A COMPARISON TO ANOTHER TEST METHOD, AN INCORRECT INTERPRETATION WAS PROVIDED FOR THIS ISOLATE. CONCLUSIONS: OTHER - 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 S AUREUS ISOLATE VANCOMYCIN (VA) MIC DISCREPANCY. THE CUSTOMER OBTAINED VANCOMYCIN SUSCEPTIBLE RESULTS ON THE PANEL AND VANCOMYCIN INTERMEDIATE RESULTS WHEN TESTED AGAINST ANOTHER TEST METHOD FOR THE ISOLATE. IT IS UNK IF THE RESULTS WERE REPORTED TO THE PHYSICIAN OR IF RESULTS WERE 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 POSITIVE COMBO 20 DRIED GRAM POSITIVE PANEL TYPE LQL SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 2011-05-07

    Patients

    Seq Age Sex Outcome Treatment
    1