BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED POS COMBO TYPE 20

    MDR report key: 952498 · Received April 17, 2007

    Report

    Report Number
    2919016-2007-00001
    Event Type
    Malfunction
    Date Received
    April 17, 2007
    Date of Event
    April 4, 2007
    Report Date
    April 17, 2007
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: METHOD; ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. RESULTS: CLINICAL ISOLATED HAS NOT YET BEEN RECEIVED FROM THE CUSTOMER. CONCLUSIONS: CLINICAL ISOLATE TESTING IS PENDING. OVERALL OXACILLIN PERFORMANCE OF DRIED POS PANELS IS ACCEPTABLE. THE CAUSE OF THE FAILURE IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED S.AUREUS ISOLATE OXACILLIN (OX) MIC DISCREPANCY. THEY OBTAINED OXACILLIN-SUSCEPTIBLE RESULTS ON THE DRIED POS COMBO TYPE 20 PANEL AND OXACILLIN-RESISTANT RESULTS ON SECONDARY METHODS THAT WERE ALSO PERFORMED FOR THE CLINICAL ISOLATE. RESULTS WERE REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCREPANT RESULT BEING OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIED POS COMBO TYPE 20 ANTIMICROBIC SUSCEPT. TEST PANELS: GRAM POS. LTT DADE BEHRING, INC. NA 2007-12-28

    Patients

    Seq Age Sex Outcome Treatment
    1 YR