BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2110543 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01632
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED. QC WAS WITHIN THE ESTABLISHED RANGES AT THE TIME OF THE EVENT. SYSTEM CHECKS PERFORMED ON (B)(6) 2011 PASSED WITHIN THE INSTRUMENT SPECIFICATIONS. THE CUSTOMER STATED A LARGE NUMBER OF PATIENTS WERE RECOVERING BELOW THE NORMAL REFERENCE RANGE AND THE DOCTOR QUESTIONED THE RESULTS STATING THEY SHOULD HAVE BEEN HIGHER. SERVICE WAS ON SITE (B)(4) 2011. THE FSE PERFORMED HARDWARE DIAGNOSTICS TO VERIFY ULTRASONICS. THE FSE ALSO VERIFIED PIPETTOR ALIGNMENT AND THAT THE PRECISION VALVE WAS OPERATING WITHOUT ISSUE. THE FSE PERFORMED A SYSTEM CHECK, WHICH PRODUCED RESULTS WITHIN INSTRUMENT SPECIFICATIONS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A LOWER THAN EXPECTED TOTAL T4 (TT4) RESULT GENERATED BY UNICEL DXC 600I ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY, AND WERE QUESTIONED BY THE PHYSICIAN BECAUSE THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. REPEAT TESTING WAS NOT PERFORMED ON THIS SAMPLE. 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® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1