BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 - FREE TRIIODOTHYRONINE

    MDR report key: 5066940 · Received September 10, 2015

    Report

    Report Number
    1823260-2015-04113
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    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 THYROTROPIN (TSH), FREE THYROXINE (FT4) AND FREE TRIIODOTHYRONINE (FT3). THE CUSTOMER HAD COMPARED RESULTS FROM THEIR E 170 ANALYZER TO AN EXTERNAL LABORATORY WHERE A LUMIPULSE ANALYZER WAS USED. THE CUSTOMER PROVIDED THE SAMPLE FOR INVESTIGATION. OF THE DATA PROVIDED, ERRONEOUS FT4 AND FT3 RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S E 170 ANALYZER, A LUMIPULSE ANALYZER, AN E 170 ANALYZER USED AT THE INVESTIGATION SITE AND AN E411 ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT3. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT4 ERRONEOUS RESULTS. NO ADVERSE EVENT WAS REPORTED. THE E 170 ANALYZER SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE FT3 REAGENT LOT NUMBER USED WITH THE E170 ANALYZER AT THE INVESTIGATION SITE WAS 185694 WITH AN EXPIRATION DATE OF 05/2016. THE FT3 REAGENT LOT NUMBER USED WITH THE E411 ANALYZER AT THE INVESTIGATION SITE WAS 183221 WITH AN EXPIRATION DATE OF 01/2016. THE SERIAL NUMBER FOR THE CUSTOMER'S E 170 ANALYZER WAS (B)(4). 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
    598943 FT3 - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1