BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1902720 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06839
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQB
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE GGT (Y-GLUTAMYLTRANSFERASE) RESULTS FOR TWO SAMPLES OF SURVEY MATERIAL. OF THE DATA PROVIDED, THE RESULTS FOR ONE OF THE SAMPLES WERE DISCREPANT. THE GGT RESULT WHEN THE ASSAY WAS RUN AS PART OF A PROFILE WAS 128 U/L AND THE RESULT WHEN THE ASSAY WAS RUN ALONE WAS 81 U/L. THE USER CALIBRATED THE ASSAY, RAN QUALITY CONTROL AND REPEATED THE ASSAY ALONE WITH A RESULT OF 85 U/L. NO PATIENT SAMPLES WERE INVOLVED IN THE EVENT. THE ISSUE WAS WITH SURVEY MATERIAL ONLY. THE GGT REAGENT LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A DEFECTIVE VALVE ASSEMBLY AND REPLACED IT. HE REPLACED THE REAGENT PROBES, MULTIPLE VALVE BLOCKS, SYRINGE SEALS, RINSE STATIONS, VACUUM PUMP, MULTIPLE SECTIONS OF RINSE MECHANISM TUBING, TEFLON SQUEEGEES AND THE REACTION CELLS AND LAMP. HE CHECKED ALL THE TUBING AND FLARES FOR THE SAMPLE PROBES, CHECKED FOR LEAKAGE, BACK-FLUSHED AND CLEANED THE REAGENT AND SAMPLE LINES, AND CHECKED THE RINSE MECHANISM FOR PROPER OPERATION, ASPIRATION AND DISPENSE. HE CHECKED ALL RINSE STATIONS FOR CORRECT WATER DISPENSE AND VACUUM, CHECKED DETERGENT DISPENSE FOR PROPER SODIUM CONCENTRATION, BACK-FLUSHED AND CLEANED THE VALVES AND METAL ELBOW FITTINGS ON TOP OF VACUUM TANK. HE BACK-FLUSHED AND CLEANED THE RINSE MECHANISM AND ALL ASSOCIATED TUBING, VALVES, DISTRIBUTION BLOCKS AND VACUUM TANK, CHECKED ALL PROBE ADJUSTMENTS, CHECKED RINSE MECHANISM ALIGNMENT, CHECKED GEAR PUMP PRESSURE SEVERAL TIMES, CHECKED PHOTOMETER READINGS AND DECONTAMINATED THE INSTRUMENT. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION AND QUALITY CONTROL WITH ALL RESULTS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JQB ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1