BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 3994331 · Received August 8, 2014

    Report

    Report Number
    1823260-2014-06037
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 22, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. A NUMBER OF SERVICE ACTIONS WERE REQUESTED TO BE PERFORMED ON THE INSTRUMENT AS PART OF THE INVESTIGATION, BUT THE CUSTOMER HAS REFUSED TO INTERRUPT THEIR LABORATORY WORK IN ORDER TO PERFORM SERVICE ACTIVITIES.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS CONFIRMED THAT THERE HAS BEEN NO ISSUES WITH UREAL ON THE INSTRUMENT SINCE THE END OF (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR SIX PATIENT SAMPLES TESTED FOR UREA/BUN (UREAL). OF THE SIX PATIENT SAMPLES, THREE WERE FOUND TO HAVE ERRONEOUS RESULTS. ALL ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ALL CORRECTED REPORTS WERE SENT TO THE DOCTOR. THE FIRST PATIENT SAMPLE INITIALLY RESULTED AS 0.1 MMOL/L. THE SAMPLE WAS AUTOMATICALLY REPEATED AND RESULTED AS 7.0 MMOL/L. THE SAMPLE WAS REPEATED AGAIN AND RESULTED AS 0.1 MMOL/L. THE SAMPLE WAS ALSO AUTOMATICALLY REPEATED AGAIN AND RESULTED AS 7.4 MMOL/L. A RESULT OF 7.0 MMOL/L WAS REPORTED OUTSIDE OF THE LABORATORY. THE SECOND PATIENT SAMPLE INITIALLY RESULTED AS 0.5 MMOL/L ON (B)(6) 2014. THE SAMPLE WAS REPEATED ON (B)(6) 2014 AND RESULTED AS 7.6 MMOL/L. THE THIRD PATIENT SAMPLE INITIALLY RESULTED AS 0.2 MMOL/L ON (B)(6) 2014. THE SAMPLE WAS REPEATED ON (B)(6) 2014 AND RESULTED AS 7.2 MMOL/L. IT WAS ASKED, BUT NO INFORMATION WAS PROVIDED ON WHETHER ANY PATIENTS WERE ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE UREAL REAGENT LOT NUMBER WAS 69855401. THE REAGENT EXPIRATION DATE WAS 02/28/2015. THE FIELD SERVICE REPRESENTATIVE CHECKED PRECISION SEVERAL TIMES. HE REPLACED ALL PROBES, CHECKED WASH VOLUME DELIVERY, CHECKED PRESSURES, AND CHECKED SYRINGE VOLUMES. HE MEASURED AMBIENT CO2 AND THIS WAS ALWAYS LOWER THAN 600. HE CHECKED THE HUMIDITY AND TEMPERATURE OF THE ENVIRONMENT CLOSE TO THE SAMPLE PROBES. HE REPLACED THE CUVETTE ROTOR. HE CLEANED THE CUVETTE ROTOR AND LUBRICATED IT. HE PERFORMED A RINSE UNIT ADJUSTMENT AND CHECKED THE ELECTRONIC VALUES FOR THE ULTRASONIC MIXER. HE PERFORMED A PROBE ADJUSTMENT FOR EACH POSITION. HE CHECKED THE LIQUID DETECTION OF THE SAMPLE PROBE AND CHECKED THE INCUBATOR TEMPERATURE. HE ALSO CLEANED AND CHECKED THE LAMP OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467789 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1