BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1891454 · Received November 4, 2010

    Report

    Report Number
    2122870-2010-00698
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THERE WERE NO ERRORS POSTED TO THE EVENT LOG OR RESULT FLAGS IN CONNECTION WITH THIS EVENT. THE CUSTOMER IS NOT QUESTIONING ANY OTHER RESULT AT THIS TIME. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI), REGARDING LOWER THAN EXPECTED TOTAL BHCG (TBHCG) RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON THIS AND ON AN ALTERNATE ANALYZER PRODUCED RESULTS WITHIN A HIGHER GESTATIONAL CATEGORY. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY, REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1