BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 3070229 · Received April 22, 2013

    Report

    Report Number
    1823260-2013-02438
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 RECEIVED QUESTIONABLE LOW ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS FOR APPROXIMATELY EIGHT PATIENT SAMPLES. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER AT THE SITE. DATA WAS ONLY PROVIDED FOR TWO OF THE PATIENT SAMPLES. PATIENT SAMPLE 1 ORIGINAL RESULT WAS 118 MMOL/L AND THE REPEAT RESULT WAS 135 MMOL/L. PATIENT SAMPLE 2 ORIGINAL RESULT WAS 115 MMOL/L AND THE REPEAT RESULT WAS EITHER 132 OR 143 MMOL/L. THE ORIGINAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS FROM THE OTHER ANALYZER WERE BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FAULTY SAMPLE MECHANISM AND REPLACED IT. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED SYSTEM DIAGNOSTICS AND ISE CHECKS SUCCESSFULLY. THE CUSTOMER RAN CALIBRATION AND QC AND ACCEPTED ALL RESULTS. THE CUSTOMER RAN A 10 CUP PRECISION SUCCESSFULLY. HE DETERMINED THE INSTRUMENT WAS PERFORMING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172398 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1