BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5800 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3747051 · Received April 11, 2014

    Report

    Report Number
    9612296-2014-00066
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 16, 2014
    Report Date
    March 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MZV
    PMA / PMN Number
    K112412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND DISCOVERED A BENT MIX PADDLE/BAR IN THE ISE DILUTION POT WHICH WAS CAUSING SPLASHES OF RESIDUE ON THE SURFACE OF THE DILUTION POT. THE FSE CLEANED THE RESIDUE AND REPLACED THE MIX PADDLE/BAR AND OTHER CONSUMABLE PARTS ON THE ISE UNIT. THE FSE VERIFIED OPERATION OF THE ISE UNIT BY PERFORMING CALIBRATION AND RUNNING A PRECISION RUN AND QC. THE FSE OBTAINED PASSING RESULTS WHICH MET PUBLISHED SPECIFICATIONS. IN CONCLUSION, FAILURE MODE OF THE EVENT IS ATTRIBUTED TO A BENT MIX PADDLE/BAR IN THE ISE DILUTION POT. RESULTS : ISE DILUTION POT MIX PADDLE/BAR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AU5800 CLINICAL CHEMISTRY ANALYZER GENERATED ERRONEOUS POTASSIUM (K) RESULTS FOR MULTIPLE PATIENTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER PROVIDED TEN (10) DISCREPANT PATIENT RESULTS WHICH ARE OUTSIDE OF THE ASSAY SPECIFICATION FOR THIS EVENT. THE CUSTOMER STATED THAT PLASMA RESIDUE WAS DISCOVERED ON THE ION SELECTIVE ELECTRODE (ISE) DILUTION POT. THE CUSTOMER ALSO FOUND A KINKED TUBING FROM THE DILUTION POT TO THE FLOWCELL AND SUSPECTED THAT THIS WAS THE CAUSE OF THE PLASMA RESIDUE ON THE INSIDE SURFACE OF THE DILUTION POT AS THE KINKED TUBING WOULD PREVENT THE ISE DILUTION POT FROM DRAINING OR CLEANING. THE CUSTOMER PUT IN PLACE A TEMPORARY MEASURE TO PREVENT THE TUBING FROM RE-KINKING. THE CUSTOMER THEN CLEANED THE DILUTION POT, CALIBRATED THE ASSAYS, AND RAN QUALITY CONTROLS (QC). THE CUSTOMER REPORTED THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATIONS AT THIS TIME. HOWEVER, AFTER RUNNING FOUR (4) HOURLY QCS, THE CUSTOMER NOTICED THAT THE POTASSIUM QC RESULTS RECOVERED OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220482 AU5800 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MZV BECKMAN COULTER AU5811-03 NA

    Patients

    Seq Age Sex Outcome Treatment
    1