BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2923617 · Received January 22, 2013

    Report

    Report Number
    2122870-2013-00042
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLW
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED SYSTEM CHECK AND LEVEL SENSE TEST AND LEVEL SENSE TEST FAILED FOR REAGENT PIPETTOR #2. THE FSE OBSERVED ONE DROP OF FLUID FORMED FROM THE TIP OF REAGENT PIPETTOR #2. THE FSE VERIFIED ALL CONNECTIONS AND TUBING; NO LOOSE CONNECTIONS OR BUBBLES WERE NOTED. THE FSE DISABLED REAGENT PIPETTOR #2 AND REPLACED THE RED/WHITE FITTING AT THE PRESSURE SENSOR. LEVEL SENSE TEST CONTINUED TO FAIL. THE FSE REPLACED THE PERISTALTIC PUMP TUBING FROM THE PRESSURE SENSOR TO THE PERISTALTIC PUMP AND THE CABLES FROM THE TRANSDUCER AND RESOLVED THE ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. QUALITY CONTROL PERFORMED WITHIN SPECIFICATION AT THE TIME OF THE EVENT. FITTING. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00041.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED THYROID-STIMULATING HORMONE (TSH) RESULTS, ABOVE THE NORMAL REFERENCE RANGE, FOR TWO PATIENTS, ON SEPARATE DAYS, INVOLVING THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. SUBSEQUENT ANALYSES OF THE PATIENTS' SAMPLE, ON THE ORIGINAL AND AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM, RECOVERED LOWER RESULTS, WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE HAS BEEN NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT TWO OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30174 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JLW BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1