BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1652533 · Received April 7, 2010

    Report

    Report Number
    1823260-2010-02051
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 7, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    USER EXPERIENCED ONGOING ISSUE WITH ERRATIC ISE RESULTS FOR TWO WEEKS. USER PROVIDED TWO PATIENT EXAMPLES WITH DISCREPANT RESULTS THAT OCCURRED ON (B) (6) 2010. SODIUM RESULTS WHICH OCCURRED ON (B) (6) 2010. SAMPLE 1, INITIAL SODIUM GAVE 118 MMOL/L AND THIS RESULT WAS NOT REPORTED. THE SAMPLE WAS MANUALLY REPEATED ON A RADIOMETER ABL 825, GIVING A SODIUM RESULT OF 140 MMOL/L. THIS RESULT WAS REPORTED. SAMPLE 2, INITIAL SODIUM GAVE 108 MMOL/L AND WAS REPORTED BUT REJECTED BY THE PHYSICIAN AS SPURIOUS. THE SAMPLE WAS MANUALLY REPEATED ON THE RADIOMETER ABL 825 GIVING A SODIUM RESULT OF 133 MMOL/L. THE RESULTS WERE CORRECTED FROM 108 TO 133 MMOL/L. THE PATIENT'S TREATMENT WAS NOT AFFECTED. PATIENTS WERE NOT ADVERSELY AFFECTED. SODIUM ELECTRODE LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE WAS MISADJUSTED. HE PERFORMED VERTICAL ADJUSTMENT OF THE SAMPLE PROBE. TO VERIFY ANALYZER PERFORMANCE HE RAN A THIRTY CUP PRECISION STUDY WITH RESULTS WITHIN SPECIFICATION. CUSTOMER RAN CALIBRATION AND CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINCIAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1