BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2165788 · Received July 17, 2011

    Report

    Report Number
    2122870-2011-02309
    Event Type
    Injury
    Date Received
    July 17, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE 1 WAS SERUM THAT WAS PROCESSED THROUGH THE CLOSED TUBE ALIQUOTTER (CTA). QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(4) 2011 MET SPECIFICATIONS. BEC SERVICE WAS ON SITE ON (B)(4) 2011 AND PERFORMED A PREVENTIVE MAINTENANCE. ALL VERIFICATION TESTING MET SPECIFICATIONS. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING A TROPONIN I (ACCUTNI) RESULT ABOVE THE AMI CUTOFF FOR ONE (1) PATIENT'S SAMPLE. THE RESULT WAS GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM USING ACCTNI REAGENT LOT 023755 AND ACCESS ACCUTNI CALIBRATOR LOT 070105. THE RESULT WAS REPORTED OUT OF THE LAB. THE PATIENT WAS BEING SEEN IN THE EMERGENCY ROOM. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE HOSPITAL, WHERE AN ADDITIONAL SAMPLE WAS TESTED FOR ACCUTNI WHICH RESULTED WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT'S ORIGINAL SAMPLE WAS RE-ANALYZED, WHICH ALSO RESULTED WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DOES NOT KNOW WHAT OTHER PATIENT TREATMENT MAY HAVE BEEN AFFECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization