BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE

    MDR report key: 3034065 · Received April 3, 2013

    Report

    Report Number
    9612296-2013-00049
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED LARGE BUBBLES IN THE REFERENCE TUBING AND THE REFERENCE VALVE APPEARED TO BE NOT ASPIRATING THE REFERENCE OR MID-STANDARD SOLUTION. THE FSE REPLACED THE REFERENCE VALVE AND NOTED THE REFERENCE ELECTRODE WAS BROKEN, AND REPLACED THE REFERENCE ELECTRODE. THE FSE RECALIBRATED THE INSTRUMENT AND PERFORMED PRECISION CHECK AND QUALITY CONTROL (QC). ALL SYSTEM TEST RESULTS RECOVERED WITHIN THE ACCEPTABLE RANGE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS SODIUM (NA) AND POTASSIUM (K) RESULTS, FOR SIX PATIENTS, AND OBSERVED BUBBLES FROM THE REFERENCE VALVE INVOLVING THE AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE (ION SELECTIVE ELECTROLYTE). THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED ALL AFFECTED PATIENT SAMPLES WERE REANALYZED BEFORE RESULTS WERE RELEASED TO THE HOSPITAL. QUALITY CONTROL (QC), PERFORMED PRIOR TO THE EVENT, WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135858 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