BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    MDR report key: 2544198 · Received April 23, 2012

    Report

    Report Number
    2122870-2012-01121
    Event Type
    Malfunction
    Date Received
    April 23, 2012
    Date of Event
    March 26, 2012
    Report Date
    March 28, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CEC
    PMA / PMN Number
    K982250
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS SENDING SAMPLES TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE ON-GOING AND NOT AVAILABLE TO DATE. SERVICE WAS NOT DISPATCHED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING LOWER THAN EXPECTED FREE T4 BELOW THE NORMAL REFERENCE RANGE FOR 15 PATIENTS ON THEIR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE, THE CUSTOMER DID NOT RECEIVE ANY REPORT DEATH OR PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND HIGHER FRT4 RESULTS WERE OBTAINED. THE RESULTS WERE EITHER WITHIN THE NORMAL REFERENCE RANGE OR BELOW THE NORMAL RESULT RANGE, HOWEVER, OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM OF 10%. SAMPLE INFORMATION WAS NOT PROVIDED. THE CUSTOMER'S FRT4 QC HAS BEEN PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT AND THE RESULTS WERE ACCEPTABLE. THE UNIT CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). SERVICE WAS NOT DISPATCHED FOR THIS EVENT. BRAND NAME: ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; CATALOG NUMBER: 973100; SERIAL NUMBER: (B)(4); DEVICE MANUFACTURE DATE: 11 MARCH 2009; 510K: K982250.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER RADIOIMMUNOASSAY, FREE THYROXINE CEC BECKMAN COULTER, INC. FREE T4 270008

    Patients

    Seq Age Sex Outcome Treatment
    1