BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1943161 · Received December 30, 2010

    Report

    Report Number
    2122870-2010-01013
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 28, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN GREEN TOP LIHEP PLASMA TUBES WITH A GEL SEPARATOR. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2010. FSE PERFORMED A HIGH-SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. FSE ALSO PERFORMED A PRECISION TEST WHICH PASSED WITHIN SPECIFICATIONS. FSE INSPECTED THE ORIGINAL SAMPLE AND NOTED A LARGE AMOUNT OF SEDIMENT. ALTHOUGH SAMPLE INTEGRITY MAY HAVE BEEN A CONTRIBUTING FACTOR, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED THYROID STIMULATING HORMONE (TSH) RESULT GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM THAT WAS QUESTIONED BY THE PHYSICIAN. SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. 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® DXL 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1