BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 6328351 · Received February 14, 2017

    Report

    Report Number
    1823260-2017-00304
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Date of Event
    January 25, 2017
    Report Date
    March 14, 2017
    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

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. A SAMPLE FROM THE PATIENT WAS REQUESTED FOR INVESTIGATION, BUT COULD NOT BE PROVIDED. A GENERAL REAGENT ISSUE COULD NOT BE DETECTED. CONTROLS WERE FOUND TO BE WITHIN SPECIFICATIONS. TO THE OBSERVED DIFFERENCES IN VALUES BETWEEN THE E170 ANALYZER AND THE E411 ANALYZER FOR THE FT4 AND FT3 ASSAYS, A BIOLOGICAL COMPONENT MAY BE PRESENT IN THE SAMPLE THAT MAY DIFFERENTLY INTERACT WITH THE ASSAY COMPONENTS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR ELECSYS FT3 III (FT3) AND THE ELECSYS FT4 II ASSAY (FT4) ON A ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER (E170) AND A COBAS E 411 IMMUNOASSAY ANALYZER (E411). IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER STATED THAT THEY HAD NO OTHER ISSUES WITH QUESTIONABLE RESULTS EXCEPT FOR THIS ONE PATIENT SAMPLE. THIS MEDWATCH WILL COVER THE FT4 ASSAY. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY. THE PATIENT SAMPLE WAS INITIALLY TESTED ON THE E170 ANALYZER AND THE RESULTS WERE 10.6 PG/ML FOR FT3 AND 4.7 NG/DL FOR FT4. THE SAMPLE WAS REPEATED ON THE E411 ANALYZER AND THE RESULTS WERE 4.9 PG/ML FOR FT3 AND 2.1 NG/DL FOR FT4. THE CUSTOMER CHECKED THE PRIMARY TUBE AND NO CLOT OR FIBRIN WAS FOUND IN THE TUBE. THE PRIMARY SAMPLE TUBE WAS CENTRIFUGED AND DISPENSED INTO A SECONDARY TUBE FOR RE-TESTING ON THE E170 AND E411 ANALYZERS. WHEN REPEATED AGAIN ON THE E170 ANALYZER, THE SAMPLE RESULTED AS 11.1 PG/ML FOR FT3 AND 4.8 NG/DL FOR FT4. WHEN REPEATED AGAIN ON THE E411 ANALYZER, THE SAMPLE RESULTED AS 5.0 PG/ML FOR FT3 AND 2.0 NG/DL FOR FT4. THE PATIENT WAS NOT ADVERSELY AFFECTED. CONTROLS WERE REPEATED THE SAME DAY ON BOTH ANALYZERS, BUT THERE WAS NO CHANGE IN CONTROL RESULTS. THE E170 ANALYZER SERIAL NUMBER WAS (B)(4). FT4 REAGENT LOT NUMBER 180429 WAS IN USE ON THIS ANALYZER. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). FT4 REAGENT LOT NUMBER 180429 WAS IN USE ON THIS ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112744 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 180429

    Patients

    Seq Age Sex Outcome Treatment
    1