BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2230180 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04774
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RUN AT 4:50 AM ON THE DAY OF THE EVENT WAS LOW BUT WITHIN THE LAB'S ESTABLISHED RANGES (THE LAB HAS A VERY WIDE RANGE). THE SYSTEM WAS CALIBRATED AT 5:08AM AND QC RUN AT 6:08AM WAS LOW. UPON SYSTEM RECALIBRATION AT 8:09AM QC WAS WITHIN RANGE AND THE SAMPLES WERE RERUN. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND EVALUATED THE INSTRUMENT AND VERIFIED PERFORMANCE BUT FOUND NO ISSUES. PER FSE, THE ISSUE WAS CAUSED BY TEMPERATURE FLUCTUATIONS IN THE LAB.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED FALSE LOW SODIUM (NA) AND/OR CHLORIDE (CL) RESULTS. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, SAMPLES WERE REPEATED AFTER TROUBLESHOOTING AND RESULTS WERE AMENDED. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1