BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400+ CLINICAL CHEMISTRY ANALYZER

    MDR report key: 827504 · Received February 6, 2007

    Report

    Report Number
    1823260-2007-01193
    Event Type
    Malfunction
    Date Received
    February 6, 2007
    Date of Event
    January 22, 2007
    Report Date
    February 6, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL VANCOMYCIN RESULTS OF 35 UG/DML AND 54 UG/ML WERE REPEATED DUE TO DATA FLAGS ASSOCIATED WITH THE RESULTS. THE SAME SPECIMENS WERE RERUN AND RECOVERED 16 UG/ML AND 9 UG/ML RESPECTIVELY. NO INFORMATION PROVIDED IF RESULTS WERE USED TO GUIDE THERAPY. FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE CHECK TESTS. RESULTS OF THE PERFORMANCE CHECK TESTS RECOVERED WITH SPECIFICATIONS. IN ADDITION, A PRECISION CHECK USING ONE OF THE PATIENT SAMPLES MENTION PREVIOUSLY WAS RUN; FIELD SERVICE REPRESENTATIVE COULD NOT DUPLICATE THE ERRATIC RECOVERY REPORTED EARLIER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA VANCOMYCIN