BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 2823113 · Received November 7, 2012

    Report

    Report Number
    1823260-2012-05655
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 5, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED THE AFFECTED SAMPLE FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE FT3 RESULT WAS SIGNIFICANTLY ABOVE THE REFERENCE RANGE. INVESTIGATIONS CONCLUDE THAT AN INTERFERING FACTOR TO THE IDIOTYPE WAS PRESENT IN THE SAMPLE AND MOST LIKELY CAUSED THE HIGH FT3 VALUE. LABELING STATES "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES CAN OCCUR."

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE, TESTED FOR FREE TRIIODOTHYRONINE (FT3). THE SAMPLE INITIALLY RESULTED AS 23.9 PG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS REPEATED ON A CENTAUR SYSTEM FOR VERIFICATION AND RESULTED AS 3.5 PG/ML. FROM THE INFORMATION PROVIDED, AN ADDITIONAL RESULT OF >20 WAS DOCUMENTED FOR THE SAME SAMPLE, BUT IT WAS NOT CLEAR IF THIS WAS A REPEAT RESULT OR A REFERENCE TO THE ORIGINAL 23.9 PG/ML VALUE. A CLARIFICATION HAS BEEN REQUESTED. THE SAME SAMPLE WAS TREATED IN A HETEROPHILE BLOCKING TUBE AND REPEATED, RESULTING AS > 20 FOR FT3. THE REPORTING UNITS FOR THIS RESULT WAS NOT SPECIFIED. A CLARIFICATION HAS BEEN REQUESTED. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE SAMPLE WAS RUN ON AN E MODULE, SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA 169205

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR