BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6155353 · Received December 8, 2016

    Report

    Report Number
    1823260-2016-01923
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 11, 2016
    Report Date
    January 24, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION STATED THAT THE ERRONEOUS TSH RESULTS WERE MOST LIKELY CAUSED BY THE BEAD MIXER ON THE INSTRUMENT THAT WAS NOT FUNCTIONING CORRECTLY (E.G. INCORRECT SPEED, INCORRECT POSITIONING AND/OR INCORRECT SHAPE) AND ADDRESSED BY THE FIELD SERVICE ENGINEER.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS LOW RESULTS FOR 1 PATIENT TESTED FOR ELECSYS TSH ASSAY (TSH) ON THE COBAS E 411 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TSH RESULT WAS 0.020 UIU/ML WITH A DATA FLAG. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. A NEW SAMPLE WAS OBTAINED ON (B)(6) 2016 AND THE TSH RESULT WAS 3.69 UIU/ML. THIS RESULT IS BELIEVED TO BE CORRECT. ON (B)(6) 2016, THE SAMPLE WAS REPEATED AND THE RESULT WAS 1.65 UIU/ML. ON (B)(6) 2016, THE SAMPLE WAS REPEATED AND THE RESULT WAS 1.61 UIU/ML. PRIOR TO MEASURING THE REPEAT RESULTS, THE SAMPLES WERE RECENTRIFUGED AND ALIQUOTED IN STANDARD CUPS. NO ADVERSE EVENT OCCURRED. THE TSH REAGENT LOT NUMBER WAS 143583. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE PINCH TUBE WAS EXCHANGED ON (B)(6) 2016. THE LAST LIQUID FLOW CLEANING WAS PERFORMED ON (B)(6) 2016. THE CUSTOMER INDICATED THERE WAS SPLASHING AROUND THE BEAD MIXER. THE FIELD SERVICE ENGINEER (FSE) EXCHANGED THE BEAD MIXER AND MADE THE NECESSARY ADJUSTMENTS. THE CUSTOMER ALSO STATED 2 CENTRIFUGES WERE CONNECTED TO THE SAME POWER SUPPLY CORD AS THIS E411 INSTRUMENT. THE FSE HAS REQUESTED THAT THE CENTRIFUGES BE MOVED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE CALIBRATION AND QUALITY CONTROL VALUES, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805164 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR