BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® FREE TRIIODOTHRONINE (FT3) ASSAY

    MDR report key: 2065996 · Received April 21, 2011

    Report

    Report Number
    2122870-2011-01063
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CDP
    PMA / PMN Number
    K973966
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. QC AND SYSTEM INFORMATION WAS NOT SUPPLIED. NO ISSUES ARE BEING REPORTED ON THE INSTRUMENT; THIS REPORTABLE EVENT IS A REAGENT RELATED ISSUE. APPLICATIONS TECHNICAL SUPPORT (ATS) TROUBLESHOT WITH THE CUSTOMER AND RESOLVED THE ISSUE WITH A NEW REAGENT. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A PATIENT'S ACCESS FREE TRIIODOTHYRONINE (FT3) - THYROID HORMONE RESULTS HAVE SHIFTED 20% LOWER WHEN USING THE REAGENT LOT 070139, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE SHIFT IS OUTSIDE THE ASSAYS PRECISION CLAIMS, WHICH IS NOTED TO BE LESS THAN OR EQUAL TO 12%. NO PATIENT RESULTS WERE PROVIDED BY THE CUSTOMER. THE CUSTOMER IS NOT REPORTING PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® FREE TRIIODOTHRONINE (FT3) ASSAY FREE TRIIODOTHRONINE (FT3) ASSAY CDP BECKMAN COULTER INC. FT3 REAGENT 070139

    Patients

    Seq Age Sex Outcome Treatment
    1