BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® FREE T4 REAGENT

    MDR report key: 2120787 · Received June 10, 2011

    Report

    Report Number
    2122870-2011-01804
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CEC
    PMA / PMN Number
    K982250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION AND TROUBLESHOOTING ACTIVITIES WERE CONDUCTED VIA TELEPHONE. BCI RECOMMENDED THAT THE CUSTOMER ESTABLISH A REFERENCE RANGE FOR FREE T4 (TO UPDATE THE RANGE THAT WAS CURRENTLY IN USE SINCE IT WAS UNKNOWN HOW THE CURRENT RANGE WAS ESTABLISHED).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT LOWER THAN EXPECTED RESULTS FOR FREE THYROXINE (FREE T4) FOR PATIENT SAMPLES ASSAYED USING THE ACCESS FREE T4 REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. IT IS CURRENTLY UNKNOWN THE NUMBER OF IMPACTED PATIENT SAMPLES. SEVERAL REQUESTS HAVE BEEN MADE TO THE CUSTOMER FOR PATIENT SAMPLE DATA. TO DATE, NO DATA HAVE BEEN RECEIVED FROM THE CUSTOMER. ALL QUALITY CONTROL RESULTS FOR FREE T4 WERE WITHIN THEIR RESPECTIVE RANGES. THE CUSTOMER WAS NOT EXPERIENCING ANY ISSUES WITH THE OTHER ASSAYS ON THE ANALYZER. FURTHER DISCUSSION WITH THE CUSTOMER REVEALED THAT THE REFERENCE RANGE IN USE AT THE TIME FOR FREE T4 WAS 0.8-1.8 NG/DL. THE CUSTOMER WAS NOT AWARE HOW THIS RANGE WAS DETERMINED FOR THEIR LABORATORY. BCI COMMUNICATED TO THE CUSTOMER THAT THE PUBLISHED RANGE IN THE BCI INSTRUCTIONS FOR USE FOR FREE T4 IS 0.61-1.12 NG/DL. BCI RECOMMENDED THAT THE CUSTOMER ESTABLISH A REFERENCE RANGE FOR FREE T4 OR TO REVIEW PUBLISHED REFERENCE RANGES TO COMPARE AGAINST THEIR CURRENT RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® FREE T4 REAGENT FREE THYROXINE TEST SYSTEM CEC BECKMAN COULTER, INC. 018460

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS 2 IMMUNOASSAY SYSTEM