BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1638790 · Received March 24, 2010

    Report

    Report Number
    2122870-2010-00106
    Event Type
    Malfunction
    Date Received
    March 24, 2010
    Date of Event
    February 28, 2010
    Report Date
    March 24, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHS
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL SAMPLE WAS TESTED IN A GREEN TOP TUBE. THE SAMPLE WAS ORIGINALLY CENTRIFUGED AT 9000 RPM FOR 3 MINUTES. THE SAMPLES WERE RE-CENTRIFUGED IN A DIFFERENT CENTRIFUGE AT 3100 RPM FOR 10 MINUTES. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES BEFORE AND AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED, AS THE CUSTOMER DID NOT BELIEVE THIS TO BE A HARDWARE ISSUE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ELEVATED CKMB RESULT ABOVE THE NORMAL REFERENCE RANGE ON ONE PATIENT SAMPLE. UPON REPEAT THE RESULTS WERE IN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LAB. THE CUSTOMER HAS NOT RECEIVED ANY REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JHS BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1