BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2141923 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02652
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 28, 2011
    Report Date
    May 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FOUND BUBBLE IN THE ION-SELECTIVE ELECTRODE (ISE) BUFFER AND OBSERVED THAT THE FITTING ON THE REAGENT BOTTLE WAS LOOSE. A BCI FIELD SERVICE ENGINEER (FSE) FOUND LINE #24 PINCHED BETWEEN THE FLOW CELL BRACKET AND THE CHASSIS. FSE ELECTROLYTE INJECTION CUP (EIC) VALVE MOD 10874 AND COMPLETED THE ISE CALIBRATION HEALTH CHECK AND PRECISION HEALTH CHECK. FSE RECEIVED A WASTE SUMP FULL ERROR WHEN PERFORMED THE QC TEST, WHICH SHUT THE ANALYZER DOWN. FSE CLEANED AND EMPTIED THE SUMP AND THE VALVE. FSE PRIMED THE INSTRUMENT 20 TIMES. FSE TESTED QC AND OBSERVED CARSOUEL MOTION ERROR. FSE RESTARTED THE INSTRUMENT AND COMPLETED THE QC TEST. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT THAT THE ELECTROLYTES FAILED CALIBRATION. SODIUM SAMPLE REFERENCES WERE INCONSISTENT. NO INJURY OR EXPOSURES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON® CHEMISTRY ANALYZER DISCRETE CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1