BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2211013 · Received August 13, 2011

    Report

    Report Number
    2122870-2011-02891
    Event Type
    Malfunction
    Date Received
    August 13, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LTJ
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERUM SAMPLE WAS CENTRIFUGED FOR 10 MINUTES AT 3400 RPM. SAMPLE APPEARANCE WAS NORMAL. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2011 FAILED THE WASHED PORTION. THE WASHED PORTION OF THE SYSTEM CHECK WAS REPEATED THE SAME DAY AND MET SPECIFICATIONS. A SYSTEM CHECK PERFORMED ON (B)(6) 2011 MET SPECIFICATIONS WITH NO ISSUES. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011. THE FSE VERIFIED THAT THE ULTRASONICS, ALIGNMENTS AND THE TRANSDUCER TEMPERATURE WERE CORRECT. ALL VERIFICATION TESTING MET PUBLISHED PERFORMANCE SPECIFICATIONS. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING AN ERRONEOUSLY NORMAL HYBRITECH PSA (HYB-PSA) RESULT FOR ONE (1) PATIENT. THE RESULT WAS GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM, USED IN CONJUNCTION WITH ACCESS HYB-PSA REAGENT (LOT 021763) AND ACCESS HYB-PSA CALIBRATOR (LOT 019788). THE RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. REPEAT ANALYSIS OF THE SAMPLE ON THE SAME INSTRUMENT YIELDED A RESULT ABOVE 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 WITH 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 FOR CLINICAL USE LTJ BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1