BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2060357 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-01004
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PLASTIC GREINER SERUM TUBE WITH A GEL SEPARATOR, AND WAS CENTRIFUGED FOR TEN MINUTES AT 3000 RPM. THE SAMPLE WAS CLEAR OF FIBRIN, A FULL DRAW AND WAS ALLOWED TO CLOT FOR 40 MINUTES PRIOR TO CENTRIFUGATION. THE SAMPLE WAS ANALYZED FROM THE PRIMARY TUBE. QC IS PERFORMED ONCE EVERY 24 HOURS, AND WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(4) 2011 AND FAILED WITH AN UNWASHED %CV OF 2.09% (SYSTEM SPECIFICATION IS 0.00-2.00%). SERVICE WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT, AND THE FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE ON THE INSTRUMENT. THE FSE DISCOVERED A LEAKING SAMPLE PUMP, AND REPLACED IT. THE FSE CALIBRATED PIPETTOR TRANSDUCER ULTRASONICS AND PRESSURE SENSORS. THE FSE PERFORMED A ROUTINE SYSTEM CHECK, A HIGH SENSITIVITY SYSTEM CHECK, A CARRYOVER TEST AND QC. ALL TESTING PASSED WITHIN SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LOWER THAN EXPECTED PROGESTERONE RESULT GENERATED ON UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY, AND QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING PRODUCED HIGHER RESULTS IN A DIFFERENT DIAGNOSTIC CATEGORY THAT BETTER MATCHED THE PATIENT'S CLINICAL PRESENTATION. 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR