BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1941381 · Received December 29, 2010

    Report

    Report Number
    1823260-2010-07737
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 16, 2010
    Report Date
    December 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE RESULT FOR TROPONIN T (TNT) ON THE COBAS E601 MODULE FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.056 NG/ML. THE USER'S LABORATORY INFORMATION SYSTEM (LIS) FLAGGED THE INITIAL RESULT WITH A DELTA CHECK AS NOT MATCHING PREVIOUS TNT RESULTS FOR THIS PATIENT. THE SAMPLE WAS REPEATED YIELDING A RESULT OF 0.01 NG/ML. ON (B)(6) 2010, THE SAMPLE WAS TESTED TWICE ON ANOTHER COBAS E601 MODULE, SERIAL NUMBER (B)(4), WHICH YIELDED THE SAME RESULT OF < 0.010 NG/ML. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG. THE TNT RESULT OF < 0.010 NG/ML WAS REPORTED OUTSIDE THE LABORATORY AND WAS BELIEVED TO BE THE CORRECT RESULT. THE PATIENT WAS NOT AFFECTED BY THIS EVENT AS THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE REAGENT LOT NUMBER FOR TNT WAS 15930001. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS SAMPLE PROBE ALIGNMENT. HE PERFORMED PROBE ALIGNMENT. PERFORMANCE TESTS WERE RUN WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR