BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1894350 · Received November 9, 2010

    Report

    Report Number
    1823260-2010-06669
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 14, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER FAILED A PROFICIENCY SURVEY FOR ONE SAMPLE TESTING FOR URIC ACID. THE SAMPLE WAS ORIGINALLY TESTED ON (B)(6) 2010 AND THE RESULT WAS 9.0 MG/DL. THE ACCEPTABLE RANGE WAS 4.6-6.7 MG/DL. ON (B)(6) 2010, THE USER RECEIVED THE RESULTS OF THE SURVEY, SO SHE PULLED THE SAMPLE FROM THE REFRIGERATOR AND REPEATED TESTING. THE REPEAT RESULT WAS 5.64 MG/DL. NO PATIENTS WERE AFFECTED BY THE EVENT. THE URIC ACID 2 REAGENT LOT NUMBER AT THE TIME THE ORIGINAL RESULT WAS GENERATED WAS 61901801. THE URIC ACID 2 REAGENT LOT NUMBER AT THE TIME THE REPEAT RESULT WAS GENERATED WAS 62505801. THE FIELD SERVICE REPRESENTATIVE FOUND THE TRANSFER HEAD HAD CORROSION ON TWO OF THE CONNECTORS. HE REPLACED THE WHOLE TRANSFER HEAD AND VERIFIED THE ANALYZER OPERATION BY RUNNING PERFORMANCE TESTS WITH ACCEPTABLE RESULTS. THE USER RAN QUALITY CONTROL WITH ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1