BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 2012393 · Received March 9, 2011

    Report

    Report Number
    1823260-2011-01304
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. BASED UPON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE EVENT WAS INSUFFICIENT SAMPLE PIPETTED DUE TO INCORRECTLY PLACED SAMPLE CONTAINERS. THE CUSTOMER WAS USING 13 MM TUBES WITHOUT THE RECOMMENDED RACK ADAPTER. THE CUSTOMER WAS ALSO USING SAMPLE CONTAINERS AS CUP-ON- TUBE THAT WERE NOT SPECIFIED FOR THE ELECSYS SYSTEM.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE THYROTROPIN (TSH) AND FREE THYROXINE (FT4) ON 2 PATIENT SAMPLES. OF THE RESULTS PROVIDED, 1 DISCREPANT TSH RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE INITIAL TSH WAS 0.070 MIU/L, WITH A DATA FLAG, AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED 5 TIMES FOR TSH, WITH RESULTS OF 4.24, 3.81 (PERFORMED ON COBAS E411 SERIAL NUMBER (B)(4)), 4.20, 0.064 WITH A DATA FLAG, AND 4.16 MIU/L. THE 4.24 MIU/L RESULT WAS SENT TO THE PHYSICIAN AS A CORRECTION. THERE WAS NO HARM TO THE PATIENT DUE TO THIS EVENT. THE TSH REAGENT LOT NUMBER WAS 159369.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 012 YR