BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5431-02 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3015267 · Received March 21, 2013

    Report

    Report Number
    9612296-2013-00044
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    NDW
    PMA / PMN Number
    K011720
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS EXPERIENCING ERRATIC VALUES FOR LITHIUM QC. THERE WERE NO REPORTED PROBLEMS WITH CALIBRATION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE FOUND THAT THE SAMPLE PROBES WERE TOO TIGHT AND THE SYRINGES HAD POSSIBLY BEEN AFFECTED BY THAT. FSE RE-LUBRICATED ALL ASSEMBLIES AND ALIGNED PROBES. FSE ALSO REPLACED TUBING AFTER A SMALL LEAK WAS FOUND IN THE WASH WATER ANTI DRIP LINE. FSE CONTINUED TO TROUBLESHOOT THE SYSTEM AND REPLACED THE SAMPLE TRANSPORT ASSEMBLY, SAMPLE SOLENOID VALVE, REAGENT SOLENOID VALVE, SWAPPED REAGENT AND SAMPLE SYRINGE DRIVERS, ADJUSTED GEAR PUMP SLIGHTLY, AND VERIFIED ALIGNMENTS. HOWEVER THE ISSUE WAS NOT RESOLVED. FSE NOTED THAT THIS CUSTOMER'S LAB HUMIDITY WAS LESS THAN 40%. THE LAB WAS ALSO MIXING TUBE TYPES TO INCLUDE RUNNING 13MM NESTED CUPS ON THE ANALYZER. FSE THEN MOVED THE LITHIUM FROM THE INNER TO THE OUTER RING AND RECOVERY ON THE OUTER RING WAS REPRODUCIBLE WITHOUT ERRORS. THERE WERE NO FURTHER ISSUES SINCE THE TEST WAS LOCATED TO THE OUTER RING. A DEFINITE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT LITHIUM INSTABILITY ON A AU5431-02 CLINICAL CHEMISTRY ANALYZER. PER CUSTOMER, SIX (6) PATIENTS WERE AFFECTED. ONE RECOVERED LOW THE OTHER FIVE RECOVERED HIGH. THERE WAS NO INJURY OR EFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118938 AU5431-02 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER NDW BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1