BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1591401 · Received February 1, 2010

    Report

    Report Number
    1823260-2010-00674
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    January 13, 2010
    Report Date
    February 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JID
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED AN AMMONIA RESULT OF 9 UMOL/L FOR ONE PATIENT SAMPLE. SHE PUT THE SAME SAMPLE BACK ON THE ANALYZER IN A DIFFERENT POSITION OF THE SAME RACK AND RECEIVED A RESULT OF 33 UMOL/L WHICH WAS AUTO VERIFIED. THE USER REPEATED THE SAME SAMPLE A THIRD TIME AND RECEIVED A RESULT OF 21 UMOL/L. THERE WAS NO AFFECT TO PATIENT BECAUSE THE RESULT OF 33 UMOL/L WAS REPORTED AND THE USER CONSIDERED THAT TO BE THE CORRECT RESULT. THE SAMPLE HAD BEEN DRAWN IN A PURPLE TOP EDTA TUBE. THE PLASMA WAS THEN POURED INTO A 13 MM CUP AND PUT ON TOP OF A CLEAN 13 X 75 MM TUBE. THE AMMONIA REAGENT LOT NUMBER WAS 61250501. THE FIELD SERVICE REPRESENTATIVE FOUND THE AIR DRYER VALVE FOR DRYING ALL THE PROBES WAS MALFUNCTIONING AND THE PLUNGER AND METAL SLEEVE WERE COATED WITH RUST LIKE MATERIAL. HE CLEANED THE AIR DRYER VALVES, REPLACED THE SAMPLE R1 AND R2 PROBES, REPLACED THE CHECK VALVE BETWEEN THE RINSE NOZZLES AND THE CONTROL VALVE, REPLACED THE REAR VACUUM DIAPHRAGM VACUUM PUMP, ADJUSTED THE WATER TO THE RINSE MECHANISM AND CHECKED THE INTERNAL PROBE RINSES. HE VERIFIED THE ANALYZER OPERATION BY RUNNING PRECISION TESTING, CALIBRATION AND QC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR