BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3873853 · Received June 16, 2014

    Report

    Report Number
    1823260-2014-04347
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 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
    AR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE ANALYZER IS OPERATING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM AND CHLORIDE RESULTS IN THEIR C501 ANALYZER. THE CUSTOMER STATED THE SODIUM AND CHLORIDE RESULTS WERE RUNNING LOWER ON THE C501 ANALYZER THAN WERE RUNNING ON A SIEMENS ANALYZER. THE CUSTOMER STATED THIS HAD BEEN OCCURRING SINCE INSTALLATION AND HAD BEEN NOTICED IN THE VALIDATION ON (B)(6) 2014. THE CUSTOMER PROVIDED RESULTS FOR ONE PATIENT WITH A DISCREPANT SODIUM RESULT. THE PATIENT'S INITIAL SODIUM RESULT WAS 115 MMOL/L ACCOMPANIED BY A DATA FLAG AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SIEMENS ANALYZER AND THE RESULT WAS 122 MMOL/L. THE CUSTOMER STATED SINCE THE PATIENT WAS ALSO CONSIDERED CRITICALLY LOW ON THE SIEMENS ANALYZER, HE WOULD NOT HAVE BEEN TREATED ANY DIFFERENTLY. THERE WERE NO ADVERSE EVENTS. THE SODIUM ELECTRODE LOT NUMBER WAS Z75 AND THE EXPIRATION DATE WAS 01/31/2015. THE FIELD SERVICE REPRESENTATIVE FOUND A FLUIDICS FAILURE. HE CLEANED AND REPLACED THE NOZZLE TIPS ON THE RINSE MECHANISM, THE ISE TUBING, AND CARTRIDGES. HE ADJUSTED THE SIPPER PROBE AND CONDITIONED THE SYSTEM. HE VERIFIED THE OPERATION OF SODIUM AND ALL THE SYSTEM CHECKS WERE SUCCESSFUL. THE CUSTOMER VERIFIED PATIENTS AND QUALITY CONTROL FROM ANOTHER LABORATORY FOR SODIUM USING TWO DIFFERENT LOT NUMBERS OF QUALITY CONTROL AND STANDARD MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353423 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR NACL| BENZONATATE| "OTHER MEDS"