BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3132720 · Received May 29, 2013

    Report

    Report Number
    1823260-2013-03204
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE FOUND A LEAK IN ONE OF THE SIPPER TUBES. HE REPLACED THE TUBE AND THE ISSUE HAS NOT RE-OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE SODIUM AND POTASSIUM RESULTS FOR ONE PATIENT ON THEIR C501 ANALYZER. THE CUSTOMER PROVIDED DATA FOR ONE DISCREPANT SODIUM RESULT. A SPECIFIC DATE FOR THIS EVENT WAS NOT PROVIDED. THE PATIENT'S INITIAL SODIUM RESULT WAS 117 MMOL/L AND IT WAS REPORTED TO THE PATIENT'S GENERAL PRACTITIONER. THE DOCTOR SENT THE PATIENT TO THE HOSPITAL BASED ON THE INITIAL RESULTS. IN THE EMERGENCY ROOM, THE PATIENT HAD ANOTHER BLOOD SAMPLE TAKEN AND THE SODIUM RESULT WAS 142 MMOL/L. BASED ON THE NEW BLOOD SAMPLE RESULT, THE PATIENT WAS SENT HOME. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 142 MMOL/L. THE PATIENT WAS NOT HARMED BY THIS EVENT. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236778 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR