BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCAN PROMPT INOCULATION SYSTEM-D

    MDR report key: 868113 · Received September 29, 2006

    Report

    Report Number
    2919016-2006-00023
    Event Type
    Malfunction
    Date Received
    September 29, 2006
    Date of Event
    September 5, 2006
    Report Date
    September 7, 2006
    Manufacturer
    DADE BEHRING, INC.
    Product Code
    JSD
    Removal / Correction Number
    FCA 000264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: 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: OTHER - 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 RETESTED A CLINICAL ISOLATE THAT THEY PREVIOUSLY OBSERVED INSUFFICIENT GROWTH WITH. CLINICAL ISOLATE YIELDED SUSCEPTIBLE ERYTHROMYCIN AND CLINDAMYCIN RESULTS WHEN USING THE IDENTIFIED PROMPT LOT. ALTERNATE PROMPT LOT GAVE RESISTANT RESULTS FOR ERYTHROMYCIN AND CLINDAMYCIN. ACCOUNT DID NOT REPORT THE SUSCEPTIBLE RESULTS TO THE DR. 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