BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1893469 · Received November 8, 2010

    Report

    Report Number
    1823260-2010-06631
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 8, 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 TROPONIN T RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.03 NG/ML AND BECAUSE OF A DELTA CHECK, THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 0.01 NG/ML. BOTH OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE PATIENT WAS ADVERSELY AFFECTED. THE TROPONIN T REAGENT LOT NUMBER WAS 15789502. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A DAMAGED BEAD MIXER AND REPLACED IT. HE VERIFIED THE ANALYZER OPERATION BY RUNNING PERFORMANCE TESTING WITH ALL RESULTS WITHIN SPECIFICATIONS.

    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
    1 026 YR