BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIED POS COMBO TYPE 21

    MDR report key: 745545 · Received July 24, 2006

    Report

    Report Number
    2919016-2006-00011
    Event Type
    Malfunction
    Date Received
    July 24, 2006
    Date of Event
    July 5, 2006
    Report Date
    July 5, 2006
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    LTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD; OTHER - CONTACTED CUSTOMER TO OBTAIN CLINICAL ISOLATE FOR EVALUATION. ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. EVALUATION RESULTS; OTHER - CLINICAL ISOLATE REQUESTED FOR EVALUATION TESTING BY DADE BEHRING. ISOLATE HAS NOT BEEN TESTED AT THIS TIME. CONCLUSIONS; OVERALL VANCOMYCIN PERFORMANCE OF DRIED POS PANELS IS ACCEPTABLE.

    Description of Event or Problem · 1

    SINGLE ACCOUNT REPORTED TO DADE BEHRING THAT THEY OBSERVED A CLINICAL E. FAECIUM ISOLATE VANCOMYCIN MIC DISCREPANCY. THE ACCOUNT OBTAINED VANCOMYCIN-SUSCEPTIBLE RESULTS ON THE DRIED POS COMBO TYPE 21 PANEL AND VANCOMYCIN-RESISTANT RESULTS ON A SECONDARY METHOD (VRE PLATE) FOR THE CLINICAL ISOLATE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES TO A PATIENT AS A RESULT OF THE FALSE SUSCEPTIBLE RESULTS 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 2007-05-04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other