BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1863928 · Received October 11, 2010

    Report

    Report Number
    2122870-2010-00606
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    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 SAMPLE WAS LITHIUM HEPARIN PLASMA THAT WAS CENTRIFUGED AT 1,300G FOR 10 MINUTES. THE SPECIMEN WAS COLLECTED BY A NURSE AND THE COLLECTION TUBE APPEARED NOT TO BE FILLED TO THE RECOMMENDED VOLUME. QC IS PERFORMED ONCE DAILY AND WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010, JUST PRIOR TO THE ERRONEOUS RESULT, AND MET SPECIFICATIONS. THE CUSTOMER IS ONLY QUESTIONING THE RESULTS OF THIS ONE SAMPLE AND DECLINED SERVICE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY ELEVATED CKMB RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FROM ONE PATIENT'S SAMPLE. THE CKMB RESULT WAS NOT REPORTED OUT OF THE LAB. UPON REPEAT TESTING THE RESULTS WERE 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