BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT4 IV

    MDR report key: 18028333 · Received October 30, 2023

    Report

    Report Number
    1823260-2023-03453
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    September 4, 2023
    Report Date
    August 29, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    UDI-DI
    07613336172780
    PMA / PMN Number
    K220456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E 801 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE CALIBRATIONS; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE QC DATA; THE QC RESULTS WERE WITHIN SPECIFICATIONS. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED BASED ON THE CALIBRATION AND QC RESULTS. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PREANALYTIC ISSUE (PIPETTING OF AN INSUFFICIENT AMOUNT OF SAMPLE OR FOAM/AIR BUBBLES ON THE SAMPLE SURFACE) AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY D3: IS THE INITIAL DISTRIBUTOR IN THE US.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH AND ELECSYS FT4 IV RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THIS MDR IS FOR THE FT4 IV ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE TSH ASSAY. THE INITIAL RESULTS WERE REPORTED TO THE DOCTOR. ON (B)(6) 2023, THE INITIAL FT4 RESULT WAS 0.968 PMOL/L. THIS RESULT WAS REPORTED AS 1.31 PMOL/L (THE LIMIT OF QUANTIFICATION LOQ OF THE ASSAY). ON (B)(6) 2023, THE REPEAT RESULT WAS 16.4 PMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851454 ELECSYS FT4 IV FREE THYROXINE CEC ROCHE DIAGNOSTICS 09043284190 67063401 07613336172780

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown