BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1644421 · Received March 30, 2010

    Report

    Report Number
    1823260-2010-01873
    Event Type
    Malfunction
    Date Received
    March 30, 2010
    Date of Event
    March 6, 2010
    Report Date
    March 30, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER HAD DISCREPANT SODIUM RESULTS FOR ONE PATIENT SAMPLE. REPEAT TESTING WAS PERFORMED AFTER RESULTS DID NOT MATCH PREVIOUS PATIENT TEST RESULTS AND SHOWED UP ON THE EXCEPTION REPORT. INITIAL SODIUM RESULT WAS 129 MMOL/L, RERUN RESULT WAS 162 MMOL/L (ACCOMPANIED BY H DATA FLAG). THE RERUN RESULT WAS REPORTED. THE SAMPLE WAS RECOLLECTED BEFORE ANY ACTION WAS TAKEN ON ERRONEOUS RESULTS. RECOLLECTED RESULT WAS NOT PROVIDED. CUSTOMER STATED DRAW TIMES ON INSTRUMENT PRINT-OUTS ARE NOT CORRECT AND WAS UNWILLING TO CLARIFY RESULTS PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND A DEFECTIVE SODIUM ELECTRODE. HE REPLACED SODIUM ELECTRODE, CHECKED ISE TUBING, MADE AN ADJUSTMENT TO ISE SIPPER PROBE AND BLEACH REAGENT PROBE. THE FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE TESTS, CALIBRATION AND QC, ALL WERE ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR