BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAM POSITIVE COMBO 33

    MDR report key: 1813040 · Received August 13, 2010

    Report

    Report Number
    2919016-2010-00009
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    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
    ID, 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. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED (B)(6) ISOLATE OXACILLIN (OX) MIC DISCREPANCY. THE HOSPITAL OBTAINED OXACILLIN-SUSCEPTIBLE RESULTS ON THE PANEL AND OXACILLIN-RESISTANT RESULTS WHEN TESTED AGAINST ANOTHER TEST METHOD FOR THE ISOLATE. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN AND 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 GRAM POSITIVE COMBO 33 DRIED GRAM POS PANEL LRG SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 2011-04-30

    Patients

    Seq Age Sex Outcome Treatment
    1