BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 5364641 · Received January 13, 2016

    Report

    Report Number
    1823260-2015-06081
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Date of Event
    November 27, 2015
    Report Date
    January 19, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE TROPONIN T REAGENT LOT NUMBER WAS 181799. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. BASED ON THE REVIEW OF THE ALARM TRACE, THERE WAS NO INDICATION OF AN ISSUE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. AS THE CLOTTING TIME COULD NOT BE PROVIDED, THIS CANNOT BE EXCLUDED AS A ROOT CAUSE. THE POSSIBLE ROOT CAUSE MAY BE RELATED TO THE TOO SHORT CENTRIFUGATION TIME OF 5 MINUTES (RECOMMENDED TIME IS 10 MINUTES) OR TOO HIGH G-FORCE OF 3577 (RECOMMENDED G-FORCE IS 1100-1300). THE CUSTOMER USES 13 MM TUBES WITHOUT INSERTS WHICH COULD ALSO CAUSE PIPETTING ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR TROPONIN T, CARDIAC T (TROPONIN T). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TROPONIN T RESULT WAS 3 NG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. A 2ND SAMPLE WAS OBTAINED AND THE RESULT WAS 62 NG/L. DUE TO THIS RESULT THE CLINICIAN REQUESTED THE INITIAL SAMPLE BE REPEATED. THE REPEAT RESULT WAS 54.3 NG/L. THE REPORT WAS AMENDED TO REFLECT THE REPEAT RESULT. NO ADVERSE EVENT OCCURRED. THE TROPONIN T REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. IT WAS NOTED THAT THE CUSTOMER WAS RUNNING 13X100 MM TUBES IN RACKS WITHOUT INSERTS. THE CUSTOMER INDICATES THEY HAVE TAKEN THE ACTION OF ENSURING THAT SAMPLE TUBES ARE RUN IN RACKS WITH INSERTS. THE LABORATORY STAFF HAS BEEN MADE AWARE THAT MANUALLY INSERTED SAMPLE TUBES SHOULD BE VERTICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22433 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR