BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1480609 · Received July 15, 2009

    Report

    Report Number
    1823260-2009-04949
    Event Type
    Malfunction
    Date Received
    July 15, 2009
    Date of Event
    June 30, 2009
    Report Date
    July 15, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZU
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE DETERMINED A DEFECTIVE SIPPER NOZZLE WAS THE CAUSE OF THE DISCREPANCIES AND HE REPLACED THE SIPPER NOZZLE. HE ALSO REPLACED SYRINGE SEALS, PERFORMED ISE SYSTEM CLEANING AND CLEANED VACUUM LINE. HE PERFORMED ISE CHECK AND RAN CALIBRATION AND CONTROLS TO VERIFY ANALYZER OPERATION.

    Description of Event or Problem · 1

    CUSTOMER STATES SHE RECEIVED ERRONEOUS RESULTS FOR SODIUM AND SHE RERAN OVER 20 SAMPLES. SHE PROVIDED ONLY THE FOLLOWING 3 PATIENT RESULTS: PATIENT 1, ORIGINAL RESULT 134, REPEAT 140MMOL PER L. PATIENT 2, ORIGINAL RESULT 126, REPEAT 140 MMOL PER L. PATIENT 3, ORIGINAL RESULT 134, REPEAT 149 MMOL PER L. CUSTOMER STATES NONE OF THE ERRONEOUS RESULTS WERE RELEASED TO PHYSICIANS FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE MZU ROCHE DIAGNOSTICS MODULAR CORE

    Patients

    Seq Age Sex Outcome Treatment
    1