BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1915154 · Received December 6, 2010

    Report

    Report Number
    1823260-2010-07169
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE SODIUM RESULTS FOR ABOUT 90 PATIENT SAMPLES WHICH WERE REPORTED OUTSIDE THE LABORATORY AND WERE DISCOVERED WHEN A PHYSICIAN COMPLAINED ABOUT THE RESULTS. THE USER REPEATED TESTING AND STATED THE LABORATORY HAD TO CORRECT RESULTS FOR 95% OF THE SAMPLES. THE USER ONLY PROVIDED DATA FOR NINE PATIENT SAMPLES, OF WHICH THE RESULTS FOR EIGHT WERE DISCREPANT. ALL RESULTS ARE IN MMOL/L. PATIENT SAMPLE 1 INITIAL RESULT WAS 130 AND THE REPEAT RESULT WAS 139. PATIENT SAMPLE 2 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 141. PATIENT SAMPLE 3 INITIAL RESULT WAS 133 AND THE REPEAT RESULT WAS 142. PATIENT SAMPLE 4 INITIAL RESULT WAS 135 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 5 INITIAL RESULT WAS 127 AND THE REPEAT RESULT WAS 135. PATIENT SAMPLE 6 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 140. PATIENT SAMPLE 7 INITIAL RESULT WAS 132 AND THE REPEAT RESULT WAS 144. PATIENT SAMPLE 8 INITIAL RESULT WAS 131 AND THE REPEAT RESULT WAS 141. THE USER STATED NONE OF THE PATIENTS HAD BEEN ADVERSELY AFFECTED. THE LOT NUMBER OF THE SODIUM ELECTRODE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A LOW WATER LEVEL AT THE RINSE STATION FROM THE TUBING. HE CLEANED THE TUBING FROM THE MANIFOLD TO THE RINSE STATION AND CLEANED THE ISE SAMPLE PROBE SHAFT. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING.

    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