BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECKMAN COULTER ACCESS TOTAL T3

    MDR report key: 488463 · Received September 18, 2003

    Report

    Report Number
    MW1029611
    Event Type
    Injury
    Date Received
    September 18, 2003
    Date of Event
    August 1, 2003
    Report Date
    September 18, 2003
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CHEMISTRY INSTRUMENT FOR TOTAL T3 TESTING CHANGED IN JULY 2003 AFTER EXTENSIVE VALIDATION TESTS. IN AUGUST REVIEW OF PT TESTING SHOWED HIGHER THAN NORMAL NUMBER OF ELEVATED TOTAL T3 LEVELS. RETESTING AND INVESTIGATION REVEALED THAT THE CO CHANGED ITS REAGENT WITH NO LEAD TIME NOTICE PROVIDED TO REPORTER AT THE TIME. SAMPLES FROM ORIGINAL VALIDATION WERE RETESTED BY ANOTHER HOSP WHICH USES SAME REAGENT AND MANUFACTURER AND SAME HIGHER RESULTS WERE DEMONSTRATED. REPORTER ALSO SENT TO INDEPENDENT LAB AT THEIR EXPENSE; TESTS SHOWED APPROPRIATE TOTAL T3 LEVELS. REPORTER IS NOW SENDING TOTAL T3 TO ANOTHER LAB UNTIL THE PROBLEM CAN BE CORRECTED. CO CONTACTED- THEY RETESTED VALIDATION SAMPLES AND FOUND DISCREPANCIES AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ACCESS TOTAL T3 REAGENT CDX BECKMAN COULTER * 215114

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention