BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2103017 · Received May 25, 2011

    Report

    Report Number
    2122870-2011-01552
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS COLLECTED IN A SERUM SEPARATOR TUBE. THE SAMPLE WAS SPUN FOR 10 MINUTES AT 3,000 RPMS. A SYSTEM CHECK PERFORMED ON (B)(6) 2011 WAS WITHIN PUBLISHED SPECIFICATIONS. QC DATA FROM (B)(6) 2011 INDICATES THAT LEVELS I AND III ARE WITHIN THE LABORATORY'S ESTABLISHED RANGES. QC LEVEL II IS SLIGHTLY OUT OF LABORATORY'S RANGES, BUT WITHIN PEER GROUP DATA. CUSTOMER DECLINED SERVICE. ROOT CAUSE IS LIKELY SAMPLE HANDLING, BUT NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED WITH DATA SUPPLIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT, ABOVE THE AMI CUTOFF, GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE SAMPLE WAS FILTERED AND REPEATED ON THE SAME ANALYZER AND ON A DIFFERENT INSTRUMENT AND RECOVERED LOWER WITHIN THE NORMAL REFERENCE RANGE ON BOTH INSTRUMENTS. THE CUSTOMER STATED THERE WAS NO DEATH OR INJURY TO PATIENT 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 MMI BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1