BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1334269 · Received March 5, 2009

    Report

    Report Number
    2050012-2009-00028
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 12, 2009
    Report Date
    March 5, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN THROUGH THE CTA (CLOSED TUBE ACCESSING) AND ONE HIGH RESULT WAS SEEN THAT CAME DOWN UPON REPEAT. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND RAN DIAGNOSTIC TROUBLESHOOTING. THE PROBE, SYRINGE AND ASSOCIATED TUBING WERE REPLACED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FALSELY ELEVATED TROPONIN (ACCUTNI) RESULT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. A PATIENT SAMPLE WHEN TESTED GAVE AN ACCUTNI RESULT OF 1.23G/ML WHICH REPEATED AT 0.02NG/ML. IT IS UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD 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 JJC BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1