BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEMS

    MDR report key: 1530391 · Received November 16, 2009

    Report

    Report Number
    2050012-2009-00123
    Event Type
    Malfunction
    Date Received
    November 16, 2009
    Date of Event
    October 14, 2009
    Report Date
    November 16, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS ACCEPTABLE AT 5:30 AM THE DAY OF THE EVENT. QC FAILED WHEN IT WAS RUN AGAIN AT 12:27 PM. PER CUSTOMER, NO INSTRUMENT FLAGS OR ERROR CODES WERE NOTED DURING THE TIME OF THIS EVENT. CUSTOMER RE-TESTED ALL PATIENT SAMPLES ANALYZED BETWEEN 5:30 AM AND 12:27 PM. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED THE GLUCOSE STIRRER MOTOR, MODULAR CHEMISTRY (MC) SYRINGE BARREL AND PLUNGER. NO OTHER GLUCOSE SERVICE CALLS WERE REPORTED TO DATE. BCI CONTINUE TO WORK WITH CUSTOMER TO OBTAIN ADDITIONAL INFORMATION ABOUT THIS EVENT. ALTHOUGH THE FSE REPLACED PARTS, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH GLUCOSE CUP RESULTS GENERATED BY THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEMS. SIX (6) ERRONEOUSLY HIGH GLUCOSE RESULTS WERE REPORTED OUT OF THE LABORATORY ON (B)(6) 2009. AMENDED RESULTS WERE ISSUED THE SAME DAY OF THE EVENT. THE ACTUAL PATIENT RESULTS WERE NOT SUPPLIED. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEMS DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1