BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2122611 · Received June 14, 2011

    Report

    Report Number
    2122870-2011-01872
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE INFORMATION WAS SUPPLIED. QC RESULTS FOR THE PAST 30 DAYS WERE ALL WITHIN SPECIFICATIONS ON (B)(6) 2011: PM WAS PERFORMED. SYSTEM CHECK WAS PERFORMED AND PASSED ALL SPECIFICATIONS. MYOGLOBIN WAS CALIBRATED ON (B)(6) 2011 AND PASSED ALL SPECIFICATIONS. SERVICE WAS NOT DISPATCHED AS CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE. NO ROOT CAUSE HAS BEEN DETERMINED TO DATE. THE CUSTOMER DECLINED SERVICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT DISCORDANCE OF A MYOGLOBIN PATIENT RESULT BETWEEN TWO ACCESS 2 INSTRUMENTS. BOTH PATIENT RESULTS WERE ELEVATED. PATIENT RESULTS ARE PROVIDED. THE RESULT WAS REPORTED OUT OF THE LABORATORY. UNKNOWN IF PATIENT TREATMENT WAS IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1