BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2240235 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03411
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 9, 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
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS COLLECTED IN A LI HEPARIN PST TUBE AND CENTRIFUGED FOR 15 MINUTES AT 3200 RPM. SAMPLE APPEARANCE WAS NORMAL AT THE TIME OF ANALYSIS. THE LABORATORY'S STANDARD PROCEDURE IS TO SPIN DOWN THE SAMPLE, ASPIRATE THE SAMPLE AND PLACE IT IN A SEPARATE TUBE. THE SAMPLE IS THEN STORED IN THE REFRIGERATOR UNTIL ANALYSIS. QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011, WHICH FAILED THE SUBSTRATE PORTION. THE SUBSTRATE PORTION OF THE SYSTEM CHECK WAS REPEATED AND MET SPECIFICATIONS. THE CUSTOMER DECLINED SERVICE TO BE DISPATCHED BECAUSE PREVENTATIVE MAINTENANCE HAD JUST BEEN PERFORMED ON THE INSTRUMENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING A TROPONIN (ACCUTNI) RESULT ON (B)(6) 2011 THAT WAS ABOVE THE AMI CUTOFF FOR ONE (1) PATIENT. THE RESULT WAS GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 110411) AND ACCESS ACCUTNI CALIBRATORS (LOT 018864). THE RESULT WAS REPORTED OUT OF THE LABORATORY. A PREVIOUS SAMPLE FROM THE SAME PATIENT ON THE PREVIOUS NIGHT YIELDED AN ACCUTNI RESULT OF 0.18 NG/ML. SUBSEQUENT TESTING ON THE SAME INSTRUMENT YIELDED RESULTS WITHIN THE RISK STRATIFICATION RANGE. THERE WERE NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT MADE IN CONNECTION 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 JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1