BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 3222510 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04221
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE DUE TO LACK OF INFORMATION PROVIDED BY THE CUSTOMER. IT WAS NOTED THAT SINCE ONLY ONE SAMPLE WAS AFFECTED, A SYSTEMATIC OR INSTRUMENT ERROR COULD BE EXCLUDED. A POTENTIAL ROOT CAUSE COULD BE PRE-ANALYTICAL PROCESS, BUT AS NO INFORMATION WAS PROVIDED BY THE CUSTOMER, THIS CAUSE CANNOT BE CONFIRMED. ANOTHER POTENTIAL ROOT CAUSE COULD BE CONTAMINATION. THE ACTIONS OF THE FIELD SERVICE REPRESENTATIVE WERE PREVENTATIVE MAINTENANCE. AS ONLY ONE SAMPLE WAS AFFECTED, CONTAMINATION COULD NOT BE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON ION SELECTIVE ELECTRODE (ISE) SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) ON ONE PATIENT SAMPLE. OF THESE RESULTS, IT WAS DETERMINED THAT THE NA AND K WERE ERRONEOUS AND HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS ARE IN MMOL/L. THE PATIENT HAD COME TO THE "ER" THE NIGHT OF (B)(6) 2013 AND HAD A "CMP". THE SAMPLE WAS DRAWN AT 21:00 ON (B)(6) 2013. THE PATIENT'S INITIAL NA RESULT WAS 126 AND THE INITIAL K RESULT WAS 6.8. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT HAD A K RESULT FROM A MONTH AGO THAT WAS 3.8. THIS FAILED THE CUSTOMER'S DELTA CHECK. SINCE THE PATIENT PRESENTED IN THE "ER" AND THE PREVIOUS RESULT WAS A MONTH OLD, THE SAMPLE WAS NOT REPEATED THE NIGHT OF (B)(6) 2013. THE PATIENT WAS ADMITTED AND TREATED FOR HYPERKALEMIA. A NEW SAMPLE WAS DRAWN (B)(6) 2013 AT 01:30 AND THE K RESULT WAS 2.4. THE PATIENT WAS IMMEDIATELY RE-DRAWN AND THE RESULT OF THAT SAMPLE WAS ALSO 2.4. THE ORIGINAL SAMPLE FROM (B)(6) 2013 AT 21:00 WAS REPEATED. THE REPEAT NA RESULT WAS 136 AND THE REPEAT K RESULT WAS 2.9. THE CUSTOMER DEEMED THE REPEAT RESULTS TO BE THE CORRECT RESULTS. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS THE RESULT OF THE TREATMENT FOR HYPERKALEMIA. THE CUSTOMER NOTED THAT THERE WAS ONLY ONE SET OF ISE REAGENTS ON THE INSTRUMENT. THE CUSTOMER ALSO REPEATED OTHER SAMPLES THAT WERE RUN AROUND 21:00 ON (B)(6) 2013 AND THEY REPEATED "JUST FINE". NO RESULTS WERE PROVIDED FOR THESE ADDITIONAL SAMPLES. THE LOT NUMBER FOR THE NA ELECTRODE IN USE WAS T59, WITH AN EXPIRATION DATE OF 11/30/2013. THE LOT NUMBER FOR THE K ELECTRODE IN USE WAS B31, WITH AN EXPIRATION DATE OF 11/30/2013. THE FIELD SERVICE REPRESENTATIVE FOUND A WORN ISE SIPPER PROBE. HE REPLACED THE WORN ISE SIPPER NOZZLE. THE CUSTOMER RAN PRECISION, THE RESULTS MET THE LABORATORY'S SPECIFICATIONS. AN ISE CHECK WAS PERFORMED AND MET SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322873 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1