BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 4848043 · Received June 16, 2015

    Report

    Report Number
    1823260-2015-03649
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    March 20, 2015
    Report Date
    July 7, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. NO SAMPLES COULD BE PROVIDED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(6) FEMALE. THE DATE OF EVENT FOR PATIENT 1 WAS CLARIFIED TO BE (B)(6) 2015. THE UNIT OF MEASURE FOR FT4 AND FT3 RESULTS IS PMOL/L. ON (B)(6) 2015, THE FT4 RESULT FOR PATIENT 2 FROM THE E602 ANALYZER WAS 21.55 PMOL/L AND THE FT3 RESULT FOR PATIENT 2 FROM THE E602 ANALYZER WAS 8.37 PMOL/L. CLARIFICATION WAS RECEIVED THAT NEITHER PATIENT EXPERIENCED AN ADVERSE EVENT. CLARIFICATION WAS RECEIVED THAT NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE RUN IN HITACHI CUPS FROM THE MODULAR PRE-ANALYTICS SYSTEM (MPA). THE CLOTTING TIME TO DRAW WAS BETWEEN 4-5 HOURS FOR ALL 3 SAMPLES. THE SAMPLES WERE RE-CENTRIFUGED BY THE MPA. LIQUID FLOW CONTROL WAS PERFORMED ON THE ASSOCIATED COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(4) ON (B)(6) 2015. THE EXPIRATION DATE FOR REAGENT LOT 181732 WAS DOCUMENTED AS 01/2016.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 2 PATIENTS TESTED FOR THYROTROPIN (TSH), FREE THYROXINE (FT4) AND FREE TRIIODOTHYRONINE (FT3). THE CUSTOMER COMPLAINED THAT THE TSH RESULTS FROM BOTH PATIENTS WERE NORMAL; HOWEVER, THE FT4 AND FT3 RESULTS FOR BOTH PATIENTS WERE HIGH. THE CUSTOMER SENT ONE SAMPLE FOR PATIENT 1 AND 2 SAMPLES FOR PATIENT 2 ((B)(6) FEMALE) TO AN EXTERNAL LABORATORY WHERE THE RESULTS FROM A DELFIA ANALYZER WERE NORMAL FOR ALL 3 PARAMETERS. BASED ON THE DATA PROVIDED, ERRONEOUS RESULTS WERE IDENTIFIED FOR TSH, FT4 AND FT3. IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT4. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE TSH ERRONEOUS RESULTS. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT3 ERRONEOUS RESULTS. IT IS NOT KNOWN IF EITHER PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE REPORTED. TESTING WAS PERFORMED ON AN E602 ANALYZER; THE ASSOCIATED COBAS 8000 CORE UNIT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391810 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 181732

    Patients

    Seq Age Sex Outcome Treatment
    1 036 YR PATIENT 1 - CARBIMAZOLE| PATIENT 2 - NO MEDICATION| PATIENT 1 - ADCAL