BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3994291 · Received August 8, 2014

    Report

    Report Number
    1823260-2014-06039
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 30, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS CONFIRMED THAT THEY HAVE HAD NO FURTHER ISSUES SINCE THE FIELD SERVICE REPRESENTATIVE PERFORMED SERVICE ACTIONS.

    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 BASED ON THE PROVIDED DATA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD MAINTENANCE PERFORMED ON THEIR DEIONIZED WATER SYSTEM AND THEN THEY STARTED HAVING ISSUES WITH THE ION SELECTIVE ELECTRODE (ISE) SODIUM TEST IMMEDIATELY AFTER THIS. THE CUSTOMER WAS ABLE TO WORK WITH THE FIELD SERVICE REPRESENTATIVE OVER THE PHONE ON (B)(6) 2014 AND AFTER THIS, THE CUSTOMER BELIEVED THEY HAD RESOLVED THE ISSUE. THE CUSTOMER THEN REPORTED THAT THEY HAD ERRONEOUS RESULTS FOR TWO PATIENT SAMPLES TESTED FOR ISE SODIUM. ALL ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST PATIENT SAMPLE INITIALLY RESULTED AS 153 MMOL/L. THE SAMPLE WAS REPEATED AND RESULTED AS 145 MMOL/L. THE SAMPLE WAS REPEATED AT A SISTER FACILITY AND THE RESULT OBTAINED FROM THIS FACILITY WAS THE FINAL RESULT SENT TO THE PHYSICIAN. THE CUSTOMER WAS ASKED, BUT COULD NOT PROVIDE THE RESULT FROM THE SISTER FACILITY. THE SECOND PATIENT SAMPLE INITIALLY RESULTED AS 147 MMOL/L. THE SAMPLE WAS REPEATED AND RESULTED AS 140 MMOL/L. THE SAMPLE WAS REPEATED AT A SISTER FACILITY AND THE RESULT OBTAINED FROM THIS FACILITY WAS THE FINAL RESULT SENT TO THE PHYSICIAN. THE CUSTOMER WAS ASKED, BUT COULD NOT PROVIDE THE RESULT FROM THE SISTER FACILITY. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE INVOLVED PATIENTS WERE ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE ISE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE ISE SIPPER PROBE WAS DAMAGED DUE TO NORMAL ANALYZER USAGE. HE REPLACED THE ISE SIPPER PROBE WITH A PART FROM THE CUSTOMER SITE. THE CUSTOMER RAN A CALIBRATION AND QUALITY CONTROLS. ALL CONTROLS WERE ACCEPTABLE TO THE CUSTOMER AND THE SYSTEM WAS FOUND TO BE PERFORMING WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472199 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1