BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCAN PROMPT INOCULATION SYSTEM-D

    MDR report key: 854692 · Received October 9, 2006

    Report

    Report Number
    2919016-2006-00035
    Event Type
    Malfunction
    Date Received
    October 9, 2006
    Date of Event
    September 22, 2006
    Report Date
    September 22, 2006
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    JSD
    Removal / Correction Number
    FCA 000264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMANCE TESTING OF CUSTOMER RETURNS AND RETENTION SAMPLES. IN-HOUSE TESTING PERFORMED AND CONFIRMED INSUFFICIENT GROWTH ISSUE WITH CUSTOMER PROVIDED SAMPLES AND ALSO WITH RETENTION SAMPLES. DADE BEHRING HAS INITIATED A FIELD CORRECTION FOR THIS ISSUE AND NOTIFIED CUSTOMER OF THE POTENTIAL FOR DISCREPANT MIC AND/OR IDENTIFICATION RESULTS WITH CLINICAL AND QC ISOLATES WITH THE IDENTIFIED PROMPT INOCULATION SYSTEM-D LOT.

    Description of Event or Problem · 1

    ACCOUNT REPORTED TO DADE BEHRING THAT THEY HAVE OBSERVED QC OUT OF RANGE IDENTIFICATION RESULTS WITH ATCC 49147 (S. BOVIS) VS. IDX, BE, PGT BIOCHEMICALS AND ATCC 29213 (S. AUREUS) VS. IDX,URE,VP BIOCHEMICALS AND AMPICILLIN. ISSUE IS ONLY WITH QC. REPORT WAS ASSOCIATED WITH ONLY THE IDENTIFIED PROMPT LOT. NO PATIENT SAMPLES WERE AFFECTED. NO REPORT OF INJURY OR ILLNESS ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSCAN PROMPT INOCULATION SYSTEM-D PANEL INOCULATING SUPPLIES JSD DADE BEHRING, INC. NA 20071127

    Patients

    Seq Age Sex Outcome Treatment
    1 YR