BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 5223531 · Received November 13, 2015

    Report

    Report Number
    1823260-2015-04542
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 27, 2015
    Report Date
    December 2, 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

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO ADDITIONAL SAMPLE VOLUME AVAILABLE FOR FURTHER INVESTIGATION. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. GIVEN THE DIFFERENT SETUPS OF ALL ASSAYS, THE ANTIBODIES USED AND THE VARIANCES IN REFERENCE METHODS, DIFFERENCES IN VALUES MAY OCCUR WHEN COMPARING THESE ASSAYS FROM DIFFERENT VENDORS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR FREE THYROXINE (FT4). THE DATE OF THE EVENT WAS ASKED FOR, BUT NOT PROVIDED. THE SAMPLE WAS INITIALLY TESTED AT THE CUSTOMER SITE ON AN E602 ANALYZER. DURING INVESTIGATIONS, THE PATIENT SAMPLE WAS TESTED ON A CENTAUR ANALYZER, A COBAS 8000 ANALYZER, AND AN E411 ANALYZER. REFER TO THE ATTACHMENT FOR THE SPECIFIC PATIENT RESULT VALUES. IT WAS ASKED, BUT IT IS UNKNOWN WHICH PATIENT RESULTS, IF ANY, WERE REPORTED OUTSIDE OF THE LABORATORY. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE E602 ANALYZER SERIAL NUMBER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE COBAS 8000 ANALYZER USED FOR INVESTIGATION PURPOSES WAS SERIAL NUMBER (B)(4). THE FT4 REAGENT LOT NUMBER USED ON THIS ANALYZER WAS 183473, WITH AN EXPIRATION DATE OF JANUARY 2016. THE E411 ANALYZER USED FOR INVESTIGATION PURPOSES WAS SERIAL NUMBER (B)(4). THE FT4 REAGENT LOT NUMBER USED ON THIS ANALYZER WAS 184927, WITH AN EXPIRATION DATE OF MARCH 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751636 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1