BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1912928 · Received December 2, 2010

    Report

    Report Number
    2122870-2010-00814
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A LITHIUM HEPARIN TUBE WITH GEL. A SYSTEM CHECK PERFORMED ON (B)(6) 2010 WAS WITHIN SPECIFICATIONS. ALL LEVELS OF QC WERE WITHIN ESTABLISHED RANGES. AFTER THE ERRONEOUS RESULT WAS OBTAINED, QC LEVELS I AND II, CALIBRATION AND A SYSTEM CHECK FAILED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE FOUND THE SUBSTRATE PROBE WAS UNSEATED ON THE WASH ARM. HE REPLACED THE PROBE. THE FSE PERFORMED DIAGNOSTIC TESTS AND CALIBRATION; ALL TESTING PASSED WITHIN PUBLISHED SPECIFICATIONS. THE FSE RAN ACCUTNI QC AND RESULTS WERE WITHIN CUSTOMER'S ESTABLISHED RANGES. HARDWARE, ADDRESSED BY THE FSE, IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT, ABOVE THE AMI CUT-OFF FOR ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LAB. THE SPECIMEN WAS RE-TESTED ON A DIFFERENT INSTRUMENT AND RECOVERED WITHIN THE NORMAL REFERENCE RANGE. THE ORIGINAL AND REPEATED PATIENT RESULTS ARE SHOWN. 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 MMI BECKMAN COULTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1