BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 3041734 · Received April 8, 2013

    Report

    Report Number
    2050012-2013-00208
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE TYPE WAS SERUM. QUALITY CONTROLS (QC) PRIOR TO THE EVENT WERE WITHIN THE LABORATORY'S SPECIFICATIONS. QC TESTED AFTER THE INITIAL RESULTS WAS OUTSIDE OF THE LABORATORY'S ACCEPTABLE RANGE FOR ALL ASSAYS. AN ATTEMPT TO CALIBRATE ALSO FAILED. BEC CUSTOMER TECHNICAL SUPPORT (CTS) PERFORMED TROUBLESHOOTING AND THE CUSTOMER FOUND THAT THE MC (MODULAR CHEMISTRY) SAMPLE SYRINGE DRIVE WAS NOT MOVING. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND FOUND THAT THE COUPLER CLAMP SETSCREWS FOR THE MC SAMPLE SYRINGE MOTOR WERE LOOSE. FSE TIGHTENED THE SETSCREWS TO THE MOTOR SHAFT AND SYRINGE GEAR AND OBSERVED THAT THE MOTION WAS GOOD. NO FURTHER PROBLEMS WITH THE MC SAMPLE SYRINGE WERE OBSERVED. THE CAUSE OF THIS EVENT IS ATTRIBUTED TO THE LOOSE SETSCREWS ON THE COUPLER CLAMP TO THE MC SAMPLE SYRINGE MOTOR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE GENERATED BY THEIR UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM WHICH WERE OUTSIDE OF THE LABORATORY'S ACCEPTABLE RANGE FOR ALL ASSAYS TESTED. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND RESULTS OBTAINED WERE CONSIDERED CORRECT BY THE CUSTOMER THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO INJURY OR AFFECT TO OR IMPACT ON PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143382 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR