BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 221<6>=ROCHE OMNI S6 SYSTEM

    MDR report key: 3734170 · Received April 8, 2014

    Report

    Report Number
    1823260-2014-02491
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 16, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJC
    PMA / PMN Number
    K945915
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE PROVIDED DATA REVEALED NO ISSUE REGARDING THE POTASSIUM ELECTRODE. ALL CALIBRATIONS AND QUALITY CONTROL MEASUREMENTS WERE WITHIN THE SPECIFICATION. THE POTASSIUM ELECTRODE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. THE CUSTOMER STATED THEY ASSUMED THE CAUSE OF THE HIGH POTASSIUM RESULTS WAS DUE TO HEMOLYSIS OF THE SAMPLES.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. THE ANALYZER WAS SHOWN TO HAVE NO ISSUES. THE FIELD SERVICE REPRESENTATIVE AND CUSTOMER ASSUMED THE DISCREPANT RESULTS WERE DUE TO HEMOLYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE POTASSIUM RESULTS ON THEIR B221 ANALYZER. THE CUSTOMER CONFIRMED THAT OVER THE WEEKEND, THERE HAD BEEN SOME OCCURRENCES OF DISCREPANT POTASSIUM RESULTS ON THEIR B221, BUT WAS UNSURE OF THE SPECIFICS. THE CUSTOMER PROVIDED A POTASSIUM RESULT OF 6 MMOL/L OBTAINED ON THE B221 ANALYZER. THE CUSTOMER STATED THE LABORATORY RESULT WAS THEN RETURNED AS 4 MMOL/L. THE CUSTOMER ALSO PROVIDED DATA FOR 1305 POTASSIUM RESULTS. INFORMATION ON WHETHER ANY OF THE RESULTS WERE FROM THE SAME PATIENT WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER ANY OF THE RESULTS WERE FROM THE SAME SAMPLE WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER ANY OF THE PATIENTS WERE ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED BUT NOT PROVIDED. THE POTASSIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210783 COBAS B 221<6>=ROCHE OMNI S6 SYSTEM BLOOD GAS ANALYZER JJC ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1