BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1880095 · Received October 22, 2010

    Report

    Report Number
    1823260-2010-06322
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 6, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION. BASED ON THE PROVIDED INFORMATION, NO CLINCIAL CHEMISTRY ASSAYS WERE INVOLVED IN THE EVENT. THE ISSUE WAS ISOLATED TO THE ISE (ION SELECTIVE ELECTRODE) MEASURING SYSTEM ON THE ANALYZER. A PROBLEM INTRODUCED BY THE USE OF THE MODULAR PRE-ANALYTICS SYSTEM (MPA) WAS EXCLUDED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE THAT WERE NORMAL WHEN REPEATED ON COBAS C501 ANALYZER SERIAL NUMBER (B)(4). THE SAMPLE WAS PROCESSED BY THE MPA (MODULAR PRE ANALYTIC) AND PLACED INTO A SAMPLE CUP FOR THE INITIAL TESTING. THE REPEAT TESTED WAS PERFORMED FROM THE ORIGINAL SAMPLE TUBE. OF THE DATA PROVIDED, THE RESULTS FOR SODIUM AND POTASSIUM WERE DISCREPANT. THE INITIAL SODIUM RESULT WAS 116 MMOL/L, REPEAT RESULT WAS 138 MMOL/L. THE INITIAL POTASSIUM RESULT WAS 4.40 MMOL/L AND THE REPEAT RESULT WAS 5.20 MMOL/L. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE LOT NUMBERS OF THE SODIUM AND POTASSIUM ELECTRODES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE AND STATED THE ISSUE APPEARED TO BE RELATED TO SAMPLE INTEGRITY. HE CHECKED THE FUNCTIONALITY OF THE RINSING OF THE CELLS AND PROBES AND NOTED THEY APPEARED TO BE FUNCTIONING NORMALLY. TO VERIFY THE ANALYZER OPERATION, THE USER RAN QUALITY CONTROL AND PATIENT SAMPLE WITH GOOD RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1