BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 311

    MDR report key: 3181597 · Received June 21, 2013

    Report

    Report Number
    1823260-2013-03755
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE LOWER RECOVERY FOR SODIUM COMPARED WITH THE ORTHO VITROS 350 MAY BE EXPLAINED BY METHODOLOGY. THE ORTHO VITROS 350 METHOD IS A DIRECT MODE METHOD WHICH CAN YIELD UP TO 7% HIGHER RESULTS THAN INDIRECT MEASUREMENTS AS PERFORMED ON THE C311 ANALYZER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PHYSICIAN HAD BEEN COMPLAINING OF LOW ION SELECTIVE ELECTRODE (ISE) SODIUM VALUES ON AN UNSPECIFIED NUMBER OF PATIENT SAMPLES SINCE (B)(6) 2013. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WHICH HAD AN ERRONEOUS ISE SODIUM RESULT ON (B)(6) 2013. THE SAMPLE INITIALLY RESULTED AS 130 MMOL/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN CALLED TO QUESTION THIS RESULT, AND DURING THIS CALL, THE PHYSICIAN STATED THAT HE HAD OBSERVED SEVERAL PATIENT REPORTS WITH LOW ISE SODIUM VALUES SINCE (B)(6) 2013 AND THIS CONCERNED HIM. THE SAMPLE WAS REPEATED ON AN ORTHO VITROS 350 ANALYZER, RESULTING AS 144 MMOL/L AND THIS VALUE WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE LOT NUMBER AND EXPIRATION DATE OF THE ISE SODIUM ELECTRODE WERE NOT PROVIDED. THE CUSTOMER NOTED ON (B)(6) 2013 THAT THEY CHANGED THE ISE DILUENT SINCE THE BOTTLE HAD EXPIRED ON BOARD. THE CUSTOMER RECALIBRATED SUCCESSFULLY AND THEN RAN A 4 PATIENT CORRELATION WITH THE ORTHO VITROS 350 ANALYZER. THE CUSTOMER COMPLETED THE CORRELATION AND NOTED THAT PATIENT VALUES WERE LOWER BY 3 TO 4 MMOL/L ON THE C311 ANALYZER WHEN COMPARED TO THE ORTHO VITROS 350 ANALYZER. SPECIFIC PATIENT VALUES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE NEEDLE VALVE ASSEMBLY WAS MISADJUSTED. HE ADJUSTED THE NEEDLE VALVE ASSEMBLY. HE RAN AN ISE CHECK AND A PRECISION STUDY. ALL CONTROLS WERE ACCEPTABLE TO THE CUSTOMER AND THE ANALYZER WAS FOUND TO BE PERFORMING WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282279 COBAS 311 CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1