BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2465937 · Received February 23, 2012

    Report

    Report Number
    2122870-2012-00484
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 3, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF ASSAY CALIBRATION RESULTS RESULTED IN THE RECOMMENDATION TO RECALIBRATE THE ASSAY AND REPEAT PATIENT RESULTS. UPON COMPLETION OF RECALIBRATION, VALID NUMERICAL PATIENT RESULTS WERE GENERATED. RECALIBRATION OF THE INSTRUMENT/ASSAY RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CARDIAC TROPONIN (ACCUTNI) NO VALUE RESULTS WITH INSTRUMENT GENERATED FLAGS WERE GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PATIENT SAMPLES. THE INSTRUMENT GENERATED FLAG WAS AN INDETERMINATE FLAG WHICH IS INDICATIVE OF A RESULT THAT CANNOT BE DISTINGUISHED FROM A SYSTEM FAILURE. IT WAS CONFIRMED THAT SHAREPACKING WAS NOT OCCURRING. THERE WERE NO ERRORS POSTED TO THE INSTRUMENT LOG. BECKMAN COULTER INC. ASSESSMENT OF INSTRUMENT ASSAY PERFORMANCE INFORMATION INDICATED THAT THE S0 ASSAY CALIBRATION STANDARD RELATIVE LIGHT UNITS (RLUS) WERE HIGHER THAN PEER VALUES. THE BECKMAN COULTER INC. TECHNICAL REPRESENTATIVE RECOMMENDED THE RECALIBRATION OF THE ASSAY WITH A NEW CALIBRATOR LOT AND THE RETESTING OF THE PATIENT SAMPLES. UPON RECALIBRATION, THE S0 RLUS WERE LOWER AND MORE IN LINE WITH PEER DATA. THE CUSTOMER REPEATED THE PATIENT RESULTS AND THE POST-RECALIBRATION ACCUTNI PATIENT RESULTS GENERATED NUMERICAL RESULTS WHICH WERE CONSIDERED VALID. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. QUALITY CONTROL RESULTS WERE GENERATING ACCEPTABLE RESULTS DURING THE TIMEFRAME OF THIS EVENT. SPECIFIC PATIENT INFORMATION, SAMPLE COLLECTION/HANDLING INFORMATION, AND ADDITIONAL SYSTEM PERFORMANCE INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI - REAGENT