BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1604810 · Received February 18, 2010

    Report

    Report Number
    2122870-2010-00063
    Event Type
    Malfunction
    Date Received
    February 18, 2010
    Date of Event
    December 30, 2009
    Report Date
    February 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PLASTIC, BD LIHEP PLASMA TUBE WITH A GEL SEPARATOR. QC PERFORMED PRIOR TO THE ERRONEOUS RESULT WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE (B)(4) 2010, CHECKED ALIGNMENTS AND REPLACED THE ASPIRATE PROBES AND THE PERI PUMP TUBING. HIGH SENSITIVITY SYSTEM CHECK WAS RAN WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. WITH AN ERRONEOUSLY ELEVATED TT3 RESULT GENERATED BY THE BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ORIGINAL RESULT REPORTED WAS 274 NG/DL AND THEN IT WAS REPEATED ON ANOTHER INSTRUMENT AND RESULTS OBTAINED WERE 142/150/143 NG/DL. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE IS NO 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1