BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCAN PROMPT INOCULATION SYSTEM - D

    MDR report key: 866312 · Received September 27, 2006

    Report

    Report Number
    2919016-2006-00017
    Event Type
    Malfunction
    Date Received
    September 27, 2006
    Date of Event
    August 30, 2006
    Report Date
    September 27, 2006
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    JSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: IN-HOUSE TESTING PERFORMED AND CONFIRMED INSUFFICIENT GROWTH ISSUE WITH CUSTOMER PROVIDED SAMPLES AND ALSO WITH RETENTION SAMPLES. CONCLUSION: INVESTIGATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    ACCOUNT REPORTED TO DADE BEHRING THAT 6 CLINICAL ISOLATES IDENTIFIED AS S HYICUS. ACCOUNT EXPECTED RESULTS TO BE S. AUREUS BASED ON POSITIVE TUBE COAGULASE TEST. ACCOUNT REPORTED TO PHYSICIAN AS S. AUREUS IDENTIFICATION BASED ON COAGULASE RESULTS. ALSO REPORTED THAT THEY HAVE EXPERIENCED INSUFFICIENT GROWTH AND SKIPPED WELL EXCEPTIONS ASSOCIATED WITH IDENTIFIED PROMPT LOT. THERE WAS NO REPORT OF INJURY OR ILLNESS ASSOCIATED WITH THE 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