BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2031435 · Received March 28, 2011

    Report

    Report Number
    1823260-2011-01641
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 24, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. THE TSH RESULTS FROM THE ELECSYS WERE CONFIRMED AS WELL AS THOSE ON THE SIEMENS CENTAUR. WITH BOTH METHODS, THE TSH RESULTS ARE SIGNIFICANTLY ABOVE THE REFERENCE RANGE. THE TSH RESULTS OBTAINED BY THE CUSTOMER ARE TRUE VALUES. THE FT4 RESULTS FROM THE ELECSYS WERE CONFIRMED AS WELL AS THOSE ON THE SIEMENS CENTAUR. WITH BOTH METHODS, THE FT4 RESULTS ARE BELOW THE REFERENCE RANGE. THE FT4 RESULTS OBTAINED BY THE CUSTOMER ARE TRUE VALUES. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR