BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2133166 · Received June 19, 2011

    Report

    Report Number
    2122870-2011-01816
    Event Type
    Malfunction
    Date Received
    June 19, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS DATA GENERATED. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT LOWER THAN EXPECTED RESULTS FOR TOTAL THYROXINE (TOTAL T4) FOR 1 PATIENT SAMPLE ASSAYED WITH ACCESS TOTAL T4 REAGENT ON AN ACCESS 2 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. THE CUSTOMER RAN THE TOTAL T4 ASSAY FOUR TIMES FOR THE PATIENT SAMPLE. THE FIRST THREE ASSAYS YIELDED A RESULT OF 0.0 UG/DL FOR TOTAL T4 FOR THE PATIENT SAMPLE. THE FOURTH ASSAY YIELDED A RESULT OF 8.10 UG/DL FOR TOTAL T4 FOR THE PATIENT SAMPLE. QUALITY CONTROL RESULTS WERE WITHIN ESTABLISHED RANGES AT THE TIME OF THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(4) 2011. THE FSE REPLACED THE PERI-PUMP TUBING, ASPIRATE PROBES, SUBSTRATE PROBE, AND THE SAMPLE PIPETTOR. ALL VERIFICATION TESTING PERFORMED MET ANALYZER SPECIFICATIONS. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL T4 REAGENT