BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 7024802 · Received November 13, 2017

    Report

    Report Number
    1823260-2017-02596
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 17, 2017
    Report Date
    November 14, 2018
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WITH SAMPLE ID (B)(6) HAD THE FOLLOWING TEST RESULTS ON (B)(6) 2018: TSH = 1.64 UIU/ML, FT4 = 1.59 NG/DL, FT3 = 6.00 PG/ML, ANTI-TSHR = 14.10 IU/ML.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED SAMPLES 171004-419, 171011-920, AND 171011-1276 FOR INVESTIGATION. THERE WAS NO REMAINING SAMPLE VOLUME AVAILABLE FOR SAMPLE 171012-445, SO NO FURTHER INVESTIGATION OF THIS SAMPLE WAS POSSIBLE. SAMPLES 171004-419 AND 171011-1276 WERE FOUND TO CONTAIN AN INTERFERING FACTOR TO A COMPONENT OF THE FT3 AND FT4 ASSAYS. THIS LIMITATION IS COVERED IN PRODUCT LABELING. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR FOUR PATIENT SAMPLES TESTED FOR ELECSYS FT3 III (FT3) AND THE ELECSYS FT4 II ASSAY (FT4) ON A COBAS 8000 E 602 MODULE (E602). IT WAS ASKED, BUT IT IS NOT KNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION RELATED TO THE FT3 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE ERRONEOUS RESULT DATA IS HIGHLIGHTED IN YELLOW. SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E602 ANALYZER. THE SAMPLES WERE THEN PROVIDED FOR INVESTIGATION, WHERE THEY WERE TESTED ON A COBAS 6000 E 601 MODULE (E601) AND A COBAS E 411 IMMUNOASSAY ANALYZER (E411). NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE E601 ANALYZER USED FOR INVESTIGATION WAS SERIAL NUMBER (B)(4). FT4 REAGENT LOT NUMBER OF 265631, WITH AN EXPIRATION DATE OF 01-SEP-2018 WAS USED ON THIS ANALYZER. THE E411 ANALYZER USED FOR INVESTIGATION WAS SERIAL NUMBER (B)(4). FT4 REAGENT LOT NUMBER OF 265631, WITH AN EXPIRATION DATE OF 01-SEP-2018 WAS USED ON THIS ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804594 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1