BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 123 <4> SYSTEM

    MDR report key: 2990975 · Received March 6, 2013

    Report

    Report Number
    1823260-2013-01331
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K111188
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). FOR THE MEDWATCH ON THE B123 ANALYZER WITH SERIAL NUMBER (B)(4), REFER TO THE MEDWATCH WITH (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE PATIENT'S SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. THE QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATION. AN INVESTIGATION OF THE SODIUM RESULT FROM THE B123 WITH SERIAL NUMBER (B)(4) SHOWED AN ABNORMAL SIGNAL CHARACTERISTIC CONTRIBUTING TO THE HIGHER RESULT. A REVIEW OF THE SIGNAL CHARACTERISTICS OF OTHER MEASUREMENTS ON THIS B123 DID NOT SHOW THE ABNORMALITIES, INDICATING A SYSTEMATIC ISSUE WAS NOT PRESENT. THE SIGNAL CHARACTERISTICS OF THE B123 WITH SERIAL NUMBER (B)(4) ALSO DID NOT SHOW THE ABNORMALITIES. THE FIELD SERVICE REPRESENTATIVE'S COMPARISON TESTS COULD NOT REPRODUCE THE DISCREPANCY/ THE CUSTOMER MATERIAL MEETS SPECIFICATION, NO PROBLEM COULD BE FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE SODIUM RESULTS FOR ONE PATIENT ON THEIR B123 ANALYZER. THE PATIENT'S SAMPLE WAS INITIALLY TESTED ON ANOTHER B123 ANALYZER, SERIAL NUMBER (B)(4), AND THE RESULT WAS 121.0 MMOL/L ACCOMPANIED BY A DATA FLAG AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON THIS B123 ANALYZER AND THE RESULT WAS 130.1 MMOL/L ACCOMPANIED BY A DATA FLAG AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER COULD NOT DETERMINE WHICH RESULT WAS CORRECT WITH RESPECT TO THE PATIENT'S CLINICAL PICTURE AND THERE WERE NO TESTS PERFORMED IN THE LABORATORY FOR COMPARISON. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE AND PERFORMED COMPARISON TESTS BETWEEN THE TWO ANALYZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96159 COBAS B 123 <4> SYSTEM BLOOD GAS ANALYZER CHL ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR