BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED POS COMBO TYPE 21

    MDR report key: 786602 · Received November 15, 2006

    Report

    Report Number
    2919016-2006-00052
    Event Type
    Malfunction
    Date Received
    November 15, 2006
    Date of Event
    October 24, 2006
    Report Date
    October 24, 2006
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SINGLE ACCOUNT REPORTED TO DADE BEHRING THAT THEY OBSERVED A CLINICAL S.AUREUS ISOLATE OXACILLIN (OX) MIC DISCREPANCY. THE ACCOUNT OBTAINED OXACILLIN SUSCEPTIBLE RESULTS ON THE DRIED POS COMBO TYPE 21 PANEL AND OXACILLIN-RESISTANT RESULTS ON SECONDARY METHODS THAT WERE ALSO PERFORMED FOR THE CLINICAL ISOLATE. ACCOUNT CORRECTLY REPORTED ISOLATE AS RESISTANT TO THE PHYSICIAN BASED ON THE RESULT OF ALTERNATE METHODS. NO REPORT OF INJURIES ASSOCIATED WITH THE SUSCEPTIBLE RESULT BEING OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIED POS COMBO TYPE 21 ANTIMICROBIC SUSCEPT. TEST PANELS: GRAM POS. LTT DADE BEHRING, INC. NA 2007-08-18

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN