BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1900802 · Received November 16, 2010

    Report

    Report Number
    2122870-2010-00757
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE CENTRIFUGED FOR 10 MINUTES AT 3500 RPM AND ALL TESTING WAS PERFORMED ON PRIMARY TUBES. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(6) 2010, AND THE RESULTS WERE WITHIN THE INSTRUMENT SPECIFICATIONS. THE CUSTOMER REPEATED OTHER HYB-PSA SAMPLES FROM THE TIME OF THE EVENT, BUT IS NOT QUESTIONING ANY OTHER RESULTS. SERVICE WAS DECLINED BY THE CUSTOMER. A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN UNEXPECTEDLY ELEVATED HYBRITECH PROSTATE SPECIFIC ANTIGEN (HYB PSA) RESULT GENERATED BY UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE POST-PROSTATECTOMY PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY AND WAS QUESTIONED BY THE CLINICIAN. SUBSEQUENT TESTING PRODUCED LOWER RESULTS OF 0.00 NG/ML, WHICH BETTER MATCHED THE PATIENT'S CLINICAL PRESENTATION. 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 SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER LTJ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1