BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 4953330 · Received July 30, 2015

    Report

    Report Number
    1823260-2015-03894
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 27, 2015
    Report Date
    July 30, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 1 PATIENT SAMPLE TESTED FOR FREE THYROXINE (FT4). THE CUSTOMER PROVIDED THE SAMPLE FOR INVESTIGATION. OF THE DATA PROVIDED, ERRONEOUS THYROTROPIN (TSH) AND FT4 RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S MODULAR ANALYTICS E-MODULE ANALYZER, A CENTAUR ANALYZER, AND AN E602 ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT4. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH ERRONEOUS RESULTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR PATIENT RESULTS. NO ADVERSE EVENT WAS REPORTED. THE E602 ANALYZER SERIAL NUMBER WAS (B)(4). THE FT4 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 183473 WITH AN EXPIRATION DATE OF 01/31/2016. THE SERIAL NUMBER FOR THE CUSTOMER'S MODULAR ANALYTICS E- MODULE ANALYZER IS NOT KNOWN. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THERE WAS NOT ENOUGH SAMPLE VOLUME LEFT TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496263 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1