BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® FREE T4

    MDR report key: 3123309 · Received May 21, 2013

    Report

    Report Number
    2122870-2013-00476
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CEC
    PMA / PMN Number
    K982250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS FREE T4 REAGENT WAS RETURNED FOR EVALUATION. SYSTEM PARAMETERS (INCLUDING QUALITY CONTROL (QC), CALIBRATIONS, AND SYSTEM CHECKS) WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. BECKMAN COULTER RECEIVED THREE PATIENT SAMPLES FROM THE CUSTOMER. SAMPLE ANALYSIS AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY PRODUCED REPRODUCIBLE FT4 RESULTS AS THE CUSTOMER OBTAINED AT THE LABORATORY. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED FREE THYROXINE (FT4) RESULT, ABOVE THE NORMAL REFERENCE RANGE, FOR ONE PATIENT, INVOLVING THE ACCESS FREE T4 UTILIZED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER REANALYZED THE SAMPLE ON THE ORIGINAL ANALYZER AND OBTAINED A REPRODUCIBLE ELEVATED VALUE. SUBSEQUENT TESTING THE PATIENT SAMPLE, THROUGH AN ALTERNATE METHODOLOGY, PRODUCED A LOWER RESULT. THE ELEVATED RESULT WAS RELEASED OUT OF THE LABORATORY, AND THE PATIENT WAS ADVISED TO DISCONTINUE TAKING THE PRESCRIBED MEDICATION UNTIL SAMPLE REANALYSIS WAS COMPLETED. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT 24 HOURS LATER, REANALYZED ON THE SAME INSTRUMENT, AND RECOVERED A LOWER FT4 RESULT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE PATIENT SAMPLES WERE COLLECTED IN 7 ML BECTON DICKINSON SERUM SEPARATOR TUBES AND REFRIGERATED FOR APPROXIMATELY TWO AND ONE HALF (2 ½) HOURS AFTER COLLECTION. THE SAMPLES WERE CENTRIFUGED FROM THE PRIMARY TUBES AT 3,344 RPM (ROTATIONS PER MINUTE) FOR 10 MINUTES, AT ROOM TEMPERATURE. QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION PRIOR TO AND AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224783 ACCESS® FREE T4 RADIOIMMUNOASSAY, FREE THYROXINE CEC BECKMAN COULTER NA 229528

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other