BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1511672 · Received October 1, 2009

    Report

    Report Number
    1823260-2009-06536
    Event Type
    Malfunction
    Date Received
    October 1, 2009
    Date of Event
    March 9, 2009
    Report Date
    October 1, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED PROBLEMS WITH VANCOMYCIN QC RECOVERY SINCE INSTALLING THE TEST SEVERAL YEARS AGO. USER REPORTS FALLING OUT HIGH ON ONE VANCOMYCIN EXTERNAL PROFICIENCY SURVEY SAMPLE IN 2009. THEY RECEIVED A SURVEY RESULT OF 6.00 UG PER ML. ACCEPTABLE SURVEY RANGE 0.00 TO 4.90 UG PER ML. THE SURVEY SAMPLE WAS REPEATED THREE MONTHS LATER USING A NEW LOT OF VANCOMYCIN REAGENT, AND RECOVERED 4.35 UG PER ML. EXACT DATE OF REPEAT TESTING NOT PROVIDED. USER DOES NOT HAVE ANY COMPLAINTS WITH PATIENT SAMPLES. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO FIND A CAUSE AND COULD NOT DUPLICATE THE ISSUE. HE PERFORMED A PIPETTOR CHECK AND FP PHOTOMETER ACCURACY CHECK. TO VERIFY ANALYZER PERFORMANCE, CALIBRATION AND CONTROLS WERE RUN. RESULTS WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER - JJE LEH ROCHE DIAGNOSTICS I400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK