BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 3081730 · Received April 29, 2013

    Report

    Report Number
    1823260-2013-02588
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    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 THEY RECEIVED COMPLAINTS FOR LOW ION SELECTIVE (ISE) SODIUM RESULTS ON PATIENT SAMPLES. THE CUSTOMER QUESTIONED A TOTAL OF TEN SAMPLES TESTED FOR ISE SODIUM. QUALITY CONTROLS AND CALIBRATION WERE ACCEPTABLE PRIOR TO RUNNING THE PATIENT SAMPLES, BUT WHEN QUALITY CONTROLS WERE CHECKED AFTER THE EVENT, THEY WERE OUT OF RANGE LOW. CALIBRATIONS WERE ALSO PERFORMED SEVERAL TIMES AFTER THE EVENT WITH THE LAST CALIBRATION FAILING OUT OF RANGE. THE CUSTOMER TRIED TO PERFORM ELECTRODE ACTIVATION, BUT THIS DID NOT RESOLVE THE ISSUE. THE CUSTOMER PROVIDED DATA FOR THREE PATIENT SAMPLES AND TWO WERE FOUND TO HAVE ERRONEOUS RESULTS. ALL SAMPLES WERE REPEATED ON INTEGRA 400 PLUS SERIAL NUMBER (B)(4) AND THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. SAMPLE ONE INITIALLY RESULTED AS 129 MMOL/L AND THIS VALUE WAS RELEASED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AND RESULTED AS 137 MMOL/L. SAMPLE TWO INITIALLY RESULTED AS 129 MMOL/L AND THIS VALUE WAS RELEASED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AND RESULTED AS 137 MMOL/L. THE PATIENTS WERE NOT ADVERSELY AFFECTED BY THE EVENT. THE ISE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE INDICATED THAT THE ISSUE WAS CAUSED BY A DAMAGED ELECTRODE. THE CAUSE OF THE ELECTRODE FAILURE COULD NOT BE DETERMINED. THE FIELD SERVICE REPRESENTATIVE CLARIFIED THAT THERE WAS NO PHYSICAL DAMAGE TO THE ELECTRODE. HE REPLACED THE SODIUM ELECTRODE. THE CUSTOMER CALIBRATED, RAN QUALITY CONTROLS, AND PRECISION; ALL WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184499 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1