BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCAN PROMPT INOCULATION SYSTEM-D

    MDR report key: 868121 · Received September 29, 2006

    Report

    Report Number
    2919016-2006-00029
    Event Type
    Malfunction
    Date Received
    September 29, 2006
    Date of Event
    September 18, 2006
    Report Date
    September 18, 2006
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    JSD
    Removal / Correction Number
    FCA 000264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: PERFORMANCE TESTING OF CUSTOMER RETURNS AND RETENTION SAMPLES. RESULTS: IN-HOUSE TESTING PERFORMED AND CONFIRMED INSUFFICIENT GROWTH ISSUE WITH CUSTOMER PROVIDED SAMPLES AND ALSO WITH RETENTION SAMPLES. CONCLUSION: DADE BEHRING HAS INITIATED A FIELD CORRECTION FOR THIS ISSUE AND NOTIFIED CUSTOMERS 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 INSUFFICIENT GROWTH (NO RESULTS) ON MICROSCAN DRIED OVERNIGHT GRAM-POSTIVE AND GRAM-NEGATIVE PANEL TYPES. REPORT WAS ASSOCIATED WITH ONLY THE IDENTIFIED PROMPT LOT. 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