BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1891456 · Received November 4, 2010

    Report

    Report Number
    2122870-2010-00697
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 7, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS BHCG SAMPLES IN BD GREEN TOPPED PLASMA TUBES. THE SPECIMENS ARE CENTRIFUGED AT 3,000 RPM FOR 8 MINUTES. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: A DIAGNOSTIC TESTING FAILED AND THE FSE REBUILT ALL REAGENT PUMPS, REPLACED LOWER PISTONS AND ROTORS, AND THE STATORS FOR REAGENT PUMP #2 AND #3. THE FSE PERFORMED PIPPETOR MATCHING AND LOW VOLUME PIPPETOR MATCHING ROUTINES, A HIGH SENSITIVITY SYSTEM CHECK AND A DILTEST; NO ISSUES WERE NOTED. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A HIGHER THAN EXPECTED TOTAL BHCG (TBHCG) RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON THIS AND ON AN ALTERNATE ANALYZER PRODUCED RESULTS WITHIN A LOWER GESTATIONAL CATEGORY. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. 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® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1