BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3191256 · Received June 26, 2013

    Report

    Report Number
    1823260-2013-03883
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. IT WAS NOTED PRE- ANALYTICAL SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ION SELECTIVE ELECTRODE (ISE) POTASSIUM. THE SAMPLE INITIALLY RESULTED AS 4.4 MMOL/L AND THIS RESULT WAS VERBALLY REPORTED OUTSIDE OF THE LABORATORY WHEN ASKED FOR IT BY THE FLOOR. WHEN THE CUSTOMER SAW OTHER VALUES FROM THE PATIENT, HE REPEATED THE SAMPLE. UPON REPEAT, THE SAMPLE RESULTED AS 3.1 MMOL/L AND THIS VALUE WAS BELIEVED TO BE CORRECT. A VERBAL CORRECTION WAS PROVIDED TO THE FLOOR. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE ISE POTASSIUM ELECTRODE LOT NUMBER WAS A83 WITH AN EXPIRATION DATE OF 10/31/2013. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED THE SYSTEM INCLUDING THE SAMPLING SYSTEM, MEASUREMENT SYSTEM, RINSE MECHANISM, AND ISE SYSTEM. HE PERFORMED A PRECISION STUDY WHICH WAS WITHIN GUIDELINES. THE OPERATOR RAN QUALITY CONTROLS AND VERIFIED THAT THE RESULTS WERE WITHIN THE CUSTOMER'S RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291381 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER CEM ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR