BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1679343 · Received May 11, 2010

    Report

    Report Number
    1823260-2010-02844
    Event Type
    Malfunction
    Date Received
    May 11, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 11, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED 40 QUESTIONABLE SODIUM RESULTS WERE GENERATED ON THE COBAS C501. THIRTY OF THESE RESULTS WERE DISCREPANT (REPEATS WERE PERFORMED ON THE SAME ANALYZER): #1: INITIAL SODIUM = 130 MMOL/L #1: REPEAT SODIUM = 139 MMOL/L #2: INITIAL SODIUM = 124 MMOL/L #2: REPEAT SODIUM = 133 MMOL/L #3: INITIAL SODIUM = 126 MMOL/L #3: REPEAT SODIUM = 134 MMOL/L #4: INITIAL SODIUM = 127 MMOL/L #4: REPEAT SODIUM = 136 MMOL/L #5: INITIAL SODIUM = 122 MMOL/L #5: REPEAT SODIUM = 129 MMOL/L #6: INITIAL SODIUM = 130 MMOL/L #6: REPEAT SODIUM = 138 MMOL/L #7: INITIAL SODIUM = 129 MMOL/L #7: REPEAT SODIUM = 138 MMOL/L #8: INITIAL SODIUM = 130 MMOL/L #8: REPEAT SODIUM = 139 MMOL/L #9: INITIAL SODIUM = 128 MMOL/L #9: REPEAT SODIUM = 137 MMOL/L #10: INITIAL SODIUM = 131 MMOL/L #10: REPEAT SODIUM = 139 MMOL/L #11: INITIAL SODIUM = 131 MMOL/L #11: REPEAT SODIUM = 140 MMOL/L #12: INITIAL SODIUM = 126 MMOL/L #12: REPEAT SODIUM = 134 MMOL/L #13: INITIAL SODIUM = 129 MMOL/L #13: REPEAT SODIUM = 138 MMOL/L #14: INITIAL SODIUM = 129 MMOL/L #14: REPEAT SODIUM = 137 MMOL/L #15: INITIAL SODIUM = 125 MMOL/L #15: REPEAT SODIUM = 133 MMOL/L #16: INITIAL SODIUM = 129 MMOL/L #16: REPEAT SODIUM = 137 MMOL/L #17: INITIAL SODIUM = 129 MMOL/L #17: REPEAT SODIUM = 137 MMOL/L #18: INITIAL SODIUM = 130 MMOL/L #18: REPEAT SODIUM = 140 MMOL/L #19: INITIAL SODIUM = 123 MMOL/L #19: REPEAT SODIUM = 131 MMOL/L #20: INITIAL SODIUM = 120 MMOL/L #20: REPEAT SODIUM = 127 MMOL/L #21: INITIAL SODIUM = 127 MMOL/L #21: REPEAT SODIUM = 135 MMOL/L #22: INITIAL SODIUM = 132 MMOL/L #22: REPEAT SODIUM = 139 MMOL/L #23: INITIAL SODIUM = 127 MMOL/L #23: REPEAT SODIUM = 137 MMOL/L #24: INITIAL SODIUM = 123 MMOL/L #24: REPEAT SODIUM = 130 MMOL/L #25: INITIAL SODIUM = 129 MMOL/L #25: REPEAT SODIUM = 138 MMOL/L #26: INITIAL SODIUM = 129 MMOL/L #26: REPEAT SODIUM = 137 MMOL/L #27: INITIAL SODIUM = 127 MMOL/L #27: REPEAT SODIUM = 135 MMOL/L #28: INITIAL SODIUM = 124 MMOL/L #28: REPEAT SODIUM = 135 MMOL/L #29: INITIAL SODIUM = 128 MMOL/L #29: REPEAT SODIUM = 136 MMOL/L #30: INITIAL SODIUM = 130 MMOL/L #30: REPEAT SODIUM = 138 MMOL/L THE CUSTOMER STATED THAT NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE VACUUM NOZZLE WAS MISALIGNED, CAUSING THE CELL TO OVERFLOW. HE ALIGNED THE SQUEEGEE NOZZLE. PERFORMANCE CHECKS WERE EXECUTED. CUSTOMER CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER CEM ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1