BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1679333 · Received May 11, 2010

    Report

    Report Number
    1823260-2010-02841
    Event Type
    Malfunction
    Date Received
    May 11, 2010
    Date of Event
    April 29, 2010
    Report Date
    May 11, 2010
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    CUSTOMER RERAN 20 ISE PATIENT SAMPLES AFTER EXPERIENCING PROBLEMS WITH CALIBRATION AND QC. FIFTEEN TO TWENTY ISE RESULTS WERE AMENDED AND CALLED TO THE RESPECTIVE DOCTORS TO REPORT THE ERRORS. ALL PATIENTS WERE OUT-PATIENTS. CUSTOMER PROVIDED ISE RESULTS FOR FOUR PATIENTS, TWO WERE DISCREPANT. ALL REPEAT RESULTS WERE PROCESSED ON THE P MODULE. PATIENT 1, INITIAL SODIUM RESULT WAS 132, REPEAT GAVE 140 MMOL/L. PATIENT 2, INITIAL SODIUM RESULT WAS 134, REPEAT GAVE 140 MMOL/L. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED. SODIUM ELECTRODE LOT # WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE THE CAUSE OF THE DISCREPANCIES. HE REPLACED ALL SYRINGE SEALS, PINCH TUBING, SAMPLE PROBE AND REAGENTS. HE CLEANED THE REACTION WELL AND RAN PERFORMANCE TESTS, CALIBRATION AND QC, ALL WERE ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1