BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2367434 · Received December 12, 2011

    Report

    Report Number
    2122870-2011-06423
    Event Type
    Malfunction
    Date Received
    December 12, 2011
    Date of Event
    November 12, 2011
    Report Date
    November 12, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S SAMPLE WAS COLLECTED IN A GLASS BD LITHIUM HEPARIN PLASMA TUBE WITH A GEL SEPARATOR. THE CUSTOMER CENTRIFUGES SAMPLES FOR THREE (3) MINUTES AT 3,000 RPM. PER CUSTOMER SUPPLIED QC CHARTS, ALL THERE LEVELS OF TSH AND T-UPTAKE QC HAVE BEEN PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES FOR THE PAST 30 DAYS. PER CUSTOMER SUPPLIED DOCUMENTATION, ROUTINE SYSTEM CHECKS WERE PERFORMED ON (B)(4) 2011 AND (B)(4) 2011; BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER PERFORMED A FOUR REPLICATE PRECISION TEST FOR BOTH TSH AND T-UPTAKE USING FOUR RANDOM PATIENT SAMPLES; THE RESULTS OBTAINED PASSED WITHIN THE ASSAYS' PRECISION CLAIMS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. ALTHOUGH SAMPLE ISSUES SUCH AS PRE-ANALYTICAL FACTORS MAY HAVE BEEN CONTRIBUTED TO THIS EVENT, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) TO REPORT OBTAINING ERRATIC THYROID-STIMULATING HORMONE (TSH), AND T-UPTAKE RESULTS FROM UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. SUBSEQUENT TESTING PRODUCED ADDITIONAL ERRATIC RESULTS OUTSIDE OF THE ASSAYS' STATED PRECISION CLAIMS OF LESS OR EQUAL 7% FOR TSH AND <10% FOR T-UPTAKE. THE RESULTS WERE NOT 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 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1