BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1891394 · Received November 4, 2010

    Report

    Report Number
    2122870-2010-00715
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE COLLECTED IN SST TUBE AND CENTRIFUGED FOR 4 MINUTES AT 3000RPM. QC WAS WITHIN THE CUSTOMERS ESTABLISHED RANGES PRE AND POST THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED A SYSTEM CHECK WHICH RESULTED IN ERROR MESSAGE AT THE SUBSTRATE PORTION. FSE REPLACED THE SUBSTRATE TUBING AND VALVE AND PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK; BOTH MET SPECIFICATION. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUS POSITIVE TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULTS ON ONE PATIENT'S SAMPLE, WHICH DID NOT MATCH THE CLINICAL PRESENTATION. THE RESULT WAS GENERATED BY UNICEL DXI 800 ACCESS CHEMISTRY ANALYZER. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE ORIGINAL SAMPLE WAS REPEATED ON THE SAME UNIT AND AN ALTERNATE UNIT AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1