BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1962028 · Received January 17, 2011

    Report

    Report Number
    2122870-2011-00036
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    November 23, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CEW
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL THREE LEVELS OF PTH QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FORT HIS EVENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ELEVATED PARATHYROID HORMONE (PTH) RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT DILUTION TESTING PRODUCED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. 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® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER CEW BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR