BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1932861 · Received December 20, 2010

    Report

    Report Number
    1823260-2010-07550
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER INFORMED THE ROCHE FIELD APPLICATION SPECIALIST OF A DISCREPANT RESULT FOR TROPONIN T (TNT) ON THE COBAS E601 MODULE. THE INITIAL TNT RESULT WAS 0.116 NG/ML. PER LABORATORY PROTOCOL, THE CUSTOMER REPEATED THE TNT TEST, TWICE ON AN ELECSYS 2010 AND ONCE ON THE ORIGINAL E601, WITH RESULTS OF <0.01 NG/ML, ACCOMPANIED BY A DATA FLAG, EACH TIME. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THE CUSTOMER STATED THE PATIENT WAS NEITHER TREATED NOR AFFECTED BY THE INITIAL RESULT. THE TNT REAGENT LOT NUMBER WAS 15789501. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED THE INSTRUMENT AND RAN PERFORMANCE TESTS, WHICH WERE ACCEPTABLE.

    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