BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED GRAM POSITIVE COMBO 33

    MDR report key: 1969941 · Received January 18, 2011

    Report

    Report Number
    2919016-2011-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 31, 2011
    Report Date
    December 31, 2011
    Manufacturer
    SIEMENS HEALTHCRE DIAGNOSTICS INC.
    Product Code
    LTT
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 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. IT IS UNK IF THE RESULTS WERE REPORTED TO THE PHYSICIAN, 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 COMBO 33 DRIED GRAM POSITIVE PANEL TYPE LTT SIEMENS HEALTHCRE DIAGNOSTICS INC. NA 2011-10-06

    Patients

    Seq Age Sex Outcome Treatment
    1