BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 600 C501 MODULE

    MDR report key: 1300773 · Received December 23, 2008

    Report

    Report Number
    1823260-2008-09424
    Event Type
    Malfunction
    Date Received
    December 23, 2008
    Date of Event
    December 6, 2008
    Report Date
    December 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    ---
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED THREE PT SAMPLES WITH DISCREPANT RESULTS FOR SODIUM AND OR BICARBONATE. INITIAL SODIUM GAVE 165 MMOL/L; REPEAT GAVE 134 MMOL/L. THE SODIUM RESULTS WERE NOT REPORTED, THEY WERE REPEATED PRIOR TO REPEATING RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE FLUID DISPENSE WAS TOO HIGH ON CELL RINSE MECHANISM AND OUTSIDE SQUEE-GEE WAS GETTING HUNG UP INTERMITTENTLY. HE CLEANED SQUEE-GEE THEN ADJUSTED FLUID DISPENSE ON RINSE MECHANISM. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    USER EXPERIENCED THREE PT SAMPLES WITH DISCREPANT RESULTS FOR SODIUM AND OR BICARBONATE. IN 2008, INITIAL SODIUM GAVE 163 MMOL/L; REPEAT GAVE 134 MMOL/L. THE SODIUM RESULTS WERE NOT REPORTED, THEY WERE REPEATED PRIOR TO REPEATING RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE FLUID DISPENSE WAS TOO HIGH ON CELL RINSE MECHANISM AND OUTSIDE SQUEE-GEE WAS GETTING HUNG UP INTERMITTENTLY. HE CLEANED SQUEE-GEE THEN ADJUSTED FLUID DISPENSE ON RINSE MECHANISM. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 3

    USER EXPERIENCED THREE PT SAMPLES WITH DISCREPANT RESULTS FOR SODIUM AND OR BICARBONATE. INITIAL BICARBONATE GAVE 49 MMOL/L; REPEAT GAVE 23 MMOL/L. THE SODIUM RESULTS WERE NOT REPORTED, THEY WERE REPEATED PRIOR TO REPEATING RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE FLUID DISPENSE WAS TOO HIGH ON CELL RINSE MECHANISM AND OUTSIDE SQUEE-GEE WAS GETTING HUNG UP INTERMITTENTLY. HE CLEANED SQUEE-GEE THEN ADJUSTED FLUID DISPENSE ON RINSE MECHANISM. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 600 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM --- ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR
    2 70 YR
    3 66 YR