BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2021220 · Received March 16, 2011

    Report

    Report Number
    2050012-2011-00600
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DKJ
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN SERUM SEPARATOR TUBE. QC WAS RUN BEFORE AND AFTER THE EVENT AND THE RESULTS WERE WITHIN ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THE COLLAR WASH STUCK WITH GEL. THE FSE REPLACED THE SAMPLE PROBES AND COLLAR WASH, PERFORMED ALIGNMENTS AND OBSTRUCTION DETECTION. THE FSE INSTRUCTED THE CUSTOMER REGARDING MINIMUM TUBE VOLUME, AND TO INSPECT THE TUBE PRIOR TO LOADING ON THE INSTRUMENT. THE FSE ALSO NOTED THAT THIS IS ON-GOING TRAINING ISSUE WITH TRAINING THIS LAB.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FALSE HIGH SALICYLATE (SALY) RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS FOR ONE PATIENT. THE INITIAL SALY RESULT OF 217.1MG/L WAS REPORTED OUT OF THE LAB. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE THE PATIENT DID NOT TAKE ANY SALICYLATE. THE CUSTOMER POURED OFF THE SAMPLE, RE-SPUN AND RERAN THE SAMPLE AND THE RESULT YIELDED <40MG/L. PATIENT TREATMENT WAS NOT AFFECTED. THE PHYSICIAN DID NOT BELIEVE THE FALSE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER DKJ BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1