BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2152840 · Received July 7, 2011

    Report

    Report Number
    2050012-2011-02913
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REPLACED BOTH SAMPLE PROBES. THE FSE ALSO REPLACED THE WASH COLLARS AND WASH COLLAR VACUUM TUBING, HOME SENSOR, THE SAMPLE WHEEL HOME SENSOR, AND THE UPPER FIBER-OPTIC HARNESS. THE FSE PERFORMED ALIGNMENT AND CLEANED THE GLUCOSE CUP. THE FSE ALSO REPLACED THE GLUCOSE SENSOR. THE FSE RETURNED AGAIN ON (B)(4) 2011 AND FOUND THAT THE GEL BUILD UP CONTINUES IN THE MC AND CC SAMPLE PROBES. THE FSE REMOVED THE SAMPLE RACK LOAD ASSEMBLY FROM THE INSTRUMENT AND FOUND THAT THE SAMPLE WHEEL MOTOR WAS RUBBING A PIECE OF GRAY PLASTIC ON THE LEFT SIDE OF THE BOX WHERE THE SAMPLE WHEEL MOTOR SITS IN. THE FSE THEN INSTALLED THE PLASTIC PROTECTOR CORRECTLY AND REPLACED THE SAMPLE WHEEL MOTOR, THE SMART MODULE THAT DRIVES THE SAMPLE WHEEL MOTOR, BOTH MC AND CC PROBES AND WASH COLLARS, BOTH MC AND CC VACUUM TUBING AND VACUUM VALVES. PER THE FSE, THE NECESSARY ALIGNMENTS WERE PERFORMED AND QC WAS RUN WITH NO ERRORS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) TO REPORT GLUCOSE ERRORS AND BUILD UP COMING FROM BOTH THE CHEMISTRY CARTRIDGE (CC) AND THE MODULAR CHEMISTRY (MC) PROBES IN THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1