BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1900958 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06780
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBC
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE (PRO-BNP II) RESULT FOR ONE PATIENT SAMPLE. THE USER FOUND A BUBBLE IN THE SAMPLE, BUT DID NOT GET AN ALARM FROM THE ANALYZER INDICATING THERE WAS A BUBBLE. THE USER REMOVED THE BUBBLE AND REPEATED TESTING. THE INITIAL RESULT WAS 162.7 PG/ML AND THE REPEAT RESULT WAS 4557 PG/ML. THE ORIGINAL RESULT WAS REPORTED OUTSIDE THE LABORATORY, BUT THE DOCTOR DID NOT SEE IT BECAUSE THE CORRECTION WAS RESULTED IN A TIMELY MANNER. THE PATIENT WAS NOT AFFECTED. THE PRO-BNP II REAGENT LOT NUMBER WAS 15712305. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A BUBBLE IN THE SAMPLE AND CONFIRMED THE USER REPEATED THE SAMPLE AFTER CLEARING THE BUBBLE. HE VERIFIED THE ANALYZER OPERATION BY PERFORMING PRECISION TESTING WITH RESULTS WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR