BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3350733 · Received September 16, 2013

    Report

    Report Number
    1823260-2013-05688
    Event Type
    Malfunction
    Date Received
    September 16, 2013
    Date of Event
    August 28, 2013
    Report Date
    November 20, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. A REVIEW OF CALIBRATION SIGNALS DETERMINED A REAGENT HANDLING ISSUE MAY HAVE BEEN INVOLVED. IT WAS ALSO NOTED THAT SEVERAL LIQUID LEVEL DETECTION ALARMS OCCURRED AROUND THE TIME OF THE EVENT. THIS TYPE OF ALARM INDICATES THE PRESENCE OF FOAM OR BUBBLES ON THE REAGENT OR INCORRECT SAMPLE PREPARATION.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A QUESTIONABLE TSH - THYROTROPIN RESULT ON ONE PATIENT SAMPLE. THE INITIAL TSH WAS 0.029 UUI/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS RETESTED TWICE WITH RESULTS OF 1.49 AND 1.46 UUI/ML. THE 1.46 UUI/ML RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO DEATH, INJURY, ILLNESS, OR DETERIORATION IN HEALTH DUE TO THE ERRONEOUS RESULT. THE PATIENT WAS NOT HARMED BY ANY ACTION TAKEN. THE LOT NUMBER OF THE TSH REAGENT WAS 172713. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465552 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR