BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2128435 · Received June 16, 2011

    Report

    Report Number
    2122870-2011-01888
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS DATA GENERATED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUSLY HIGH RESULTS FOR THYROID STIMULATING HORMONE (TSH) FOR 1 PATIENT SAMPLE ASSAYED WITH ACCESS HYPERSENSITIVE HTSH REAGENT ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. DURING TROUBLESHOOTING, A SYSTEM CHECK PERFORMED BY THE CUSTOMER FAILED TO MEET ANALYZER SPECIFICATIONS. ADDITIONAL TROUBLESHOOTING REVEALED THAT THE ASPIRATE PROBES AND THE PERI-PUMP TUBING REQUIRED REPLACING. A SYSTEM CHECK WAS PERFORMED AFTER THE ASPIRATE PROBES AND PERI-PUMP TUBING WERE REPLACED. THE SYSTEM CHECK MET ALL ANALYZER SPECIFICATIONS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS HYPERSENSITIVE HTSH REAGENT