BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1935021 · Received December 21, 2010

    Report

    Report Number
    2122870-2010-00929
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE SODIUM HEPARIN PLASMA COLLECTED BY THE ER NURSES IN PST TUBES. THE SAMPLES WERE CENTRIFUGED FOR 6 MINUTES AT 4,400 RPMS. QC IS PERFORMED ONCE A DAY AND WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 AND MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND NO HARDWARE ISSUES WERE NOTED. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A CKMB RESULT, ABOVE THE NORMAL REFERENCE RANGE, GENERATED BY THE ACCESS® 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. REPEAT TESTING AND A SUBSEQUENT SAMPLE RESULTED WITHIN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED 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 JJE BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1