BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3141136 · Received June 3, 2013

    Report

    Report Number
    2122870-2013-00506
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM TROUBLESHOOTING VIA THE TELEPHONE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO SEPARATE INDETERMINATE (IND) FLAGS FOR TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR TWO PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. SUBSEQUENT ANALYSIS OF THE PATIENTS¿ SAMPLES, ON AN ALTERNATE ACCESS 2 INSTRUMENT, RECOVERED LOWER RESULTS OF 0.01 NG/ML AND 0.004 NG/ML, WHICH WERE WITHIN THE NORMAL REFERENCE RANGE AND REPORTED TO THE HOSPITAL. THE FALSE IND FLAGGED RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER PERFORMED SYSTEM TROUBLESHOOTING AND NOTED SYSTEM CHECK FAILED WITH RELATIVE LIGHT UNITS (RLU) ERROR AND ELEVATED PERCENT COEFFICIENT OF VARIATION (%CV) ON THE WASH CYCLE. THE CUSTOMER VERIFIED THE FITTING ON THE SUBSTRATE BOTTLE AND PERFORMED WEEKLY MAINTENANCE AND REPEATED SYSTEM CHECK. SYSTEM CHECK FAILED WITH RLU ERRORS AND MULTIPLE SPECIFICATIONS OUT OF RANGE. THE CUSTOMER ALSO NOTED SAMPLE COUNTS OUTSIDE OF LIMITS SYSTEM ERROR ON THE EVENT LOG. THE CUSTOMER VERIFIED THE SUBSTRATE BOTTLE AND FITTING AND NOTED THE FITTING ON THE BOTTLE WERE LOOSE. THE CUSTOMER TIGHTENED AND VERIFIED THE SUBSTRATE PROBE, TUBING AND FITTING, AND AGAIN NOTED THE FITTING WAS SLIGHTLY LOOSE. THE CUSTOMER TIGHTENED THE FITTING AND PRIMED THE SUBSTRATE TEN TIMES THEN PERFORMED AND COMPLETED A SUCCESSFUL SYSTEM CHECK. THE CUSTOMER ANALYZED ONE PATIENT SAMPLE TEN TIMES AND NO SYSTEM ERRORS WERE NOTED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243214 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1