BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE

    MDR report key: 2944715 · Received February 5, 2013

    Report

    Report Number
    9612296-2013-00013
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    October 31, 2012
    Report Date
    January 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE PINCH VALVE, DRAIN, AND ION SELECTIVE ELECTROLYTE (ISE) TUBING SET. THE FSE ALSO REPLACED THE ELECTRODES AND SAMPLE PROBE. THE FSE PERFORMED THREE CONSECUTIVE SUCCESSFUL CALIBRATIONS AND COMPLETED MID SOLUTION REST. THE FSE REPLACED THE DETERGENT ROLLER PUMP TUBING AND DRAINED THE DETERGENT BOTTLE. THE FSE PERFORMED QUALITY CONTROL (QC) SUCCESSFULLY. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. THIS MEDWATCH REPORT IS RELATED TO MDR 9612296-2013-00012.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SPORADIC LOW SODIUM (NA) PATIENT RESULTS, ON SEPARATE DAYS, INVOLVING THE AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE. THE CUSTOMER STATED SUBSEQUENT TESTING RECOVERED ACCEPTABLE SODIUM RESULTS. THE CUSTOMER PERFORMED SYSTEM TROUBLESHOOTING BUT COULD NOT RESOLVE THE ISSUE. THE LOW RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATIONS DURING THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT TWO OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49224 AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1