BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1272029 · Received December 19, 2008

    Report

    Report Number
    2122870-2008-00422
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    November 28, 2008
    Report Date
    December 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM CHECK PERFORMED IN 2008 PASSED SPECIFICATIONS. QC AND A DIAGNOSTIC SYSTEM CHECK PERFORMED AFTER THE EVENT FAILED. A FIELD SERVICE ENGINEER WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND FOUND A CRACK IN THE PERI-PUMP TUBING. THE TUBING WAS REPLACED AND ALL HARDWARE VERIFICATION TESTING PASSED WITHIN SPECIFICATIONS. THE FSE WENT BACK TO THE CUSTOMER'S LAB AND REPLACED THE PERI-PUMP ASSEMBLY. THE FSE PERFORMED HARDWARE VERIFICATION TESTING WITH GOOD RESULTS. THE HARDWARE FAILURES MAY HAVE AFFECTED OTHER PIVOTAL ASSAYS ON RECUR. ERRONEOUS RESULTS OF A PIVOTAL ASSAY MAY CONTRIBUTE TO SERIOUS INJURY TO A PT. HARDWARE ISSUE ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING MULTIPLE ERRONEOUS RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. CUSTOMER INDICATED THAT THEY OBTAINED ERRONEOUS RESULTS ON FIVE DIFFERENT ASSAYS (RUBELLA IPG, PSA, VITAMIN B12, FERRITIN, TSH). PER CUSTOMER, THEY REPEATED ALL TESTS BACK TO THE LAST ACCEPTABLE QC AND THERE WERE 81 REPORTS THAT WERE CORRECTED. THIRTY THREE OF THOSE CORRECTED RESULTS WERE IN A DIFFERENT CLINICAL CATEGORY. THE RESULTS WERE REPORTED OUT OF THE LAB. IT IS UNK IF PT TREATMENT WAS AFFECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA