BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 3062856 · Received April 17, 2013

    Report

    Report Number
    1823260-2013-02334
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 7, 2013
    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

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. A REAGENT OR CALIBRATOR ISSUE CAN BE EXCLUDED BECAUSE THE CORRECT RESULTS WERE PRODUCED ON REPEAT. NO PROBLEMS COULD BE FOUND WITH THE INSTRUMENT. THERE HAVE BEEN NO FURTHER ISSUES REPORTED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE FREE TRIIODOTHYRONINE (FT3) RESULT FOR ONE PATIENT ON THEIR E411 ANALYZER. NO PROBLEMS WERE FOUND IN THE SAMPLE OR THE REAGENT. THE INSIDE OF THE REAGENT BOTTLE WAS CHECKED. REPEAT TESTING WAS REASONABLE AND REPRODUCIBLE. THERE WERE NO PROBLEMS WITH ANY OTHER SAMPLES. THE PATIENT'S INITIAL FT3 RESULT WAS 32.55 PG/ML AND IT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE FIRST REPEAT RESULT WAS 2.3 PG/ML. THE SECOND REPEAT RESULT WAS 2.47 PG/ML. ONE OF THE REPEAT RESULTS WAS REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS OCCURRED. THE FT3 REAGENT LOT NUMBER WAS 16920503 AND THE EXPIRATION DATE WAS 11/29/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165672 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1