BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3850695 · Received June 5, 2014

    Report

    Report Number
    1823260-2014-04031
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    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).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPEATED THE SAMPLES AND PRODUCED RESULTS COMPARABLE TO THOSE PRODUCED IN THE INVESTIGATION. THE FT3 RESULT WAS 3.87 PG/ML. THESE RESULTS WERE CONSIDERED CORRECT.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER ALLEGATION COULD NOT BE REPRODUCED. BASED UPON THE INFORMATION PROVIDED FOR INVESTIGATION, A GENERAL REAGENT ISSUE COULD NOT BE DETECTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE TRIIODOTHYRONINE (FT3) RESULTS FOR ONE PATIENT ON THEIR E411 ANALYZER. THE PATIENT'S INITIAL FT3 RESULTS WERE 6.74 PG/ML AND 6.28 PG/ML. INFORMATION ON WHETHER EITHER OF THESE RESULTS WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER PERFORMED A RECOVERY TEST USING A PEG PRECIPITATION. THE CUSTOMER RETURNED THE PATIENT'S SAMPLE FOR INVESTIGATION. THE PATIENT'S INVESTIGATION RESULTS WERE 3.52 PG/ML AND 3.55 PG/ML. THESE RESULTS WERE REPORTED TO THE CUSTOMER ON (B)(6) 2014. THE CUSTOMER PERFORMED ANOTHER MEASUREMENT ON THE PATIENT'S SAMPLES AND OBTAINED THE SAME RESULTS AS THE INVESTIGATION. THERE WERE NO DEATHS, INJURIES, ILLNESSES, DETERIORATIONS IN HEALTH, OR HARM TO THE PATIENT ASSOCIATED WITH THE ERRONEOUS RESULTS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE FT3 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329738 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1