BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3232431 · Received July 18, 2013

    Report

    Report Number
    2122870-2013-00617
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL SYSTEM PARAMETERS INCLUDING QUALITY CONTROL (QC) AND CALIBRATIONS WERE WITHIN THE ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT NOTE ANY ISSUES WITH SAMPLE COLLECTION, PROCESSING, AND HANDLING. THE CUSTOMER DID FILTER THE SAMPLE AFTER THE INITIAL RESULT WAS OBTAINED. UPON EVALUATING THE ANALYZER, THE FSE FOUND MULTIPLE ISSUES WITH THE ANALYZER. THE FSE FOUND A SPILL IN BOTH THE WASH WHEEL AND INCUBATOR BELT TRACK. THE FSE REPLACED A WORN MAIN PIPETTOR TIP AND PERI-PUMP TUBING, A BENT ASPIRATE PROBE, AND THE SUBSTRATE PROBE WHICH WAS FOUND TO HAVE A SLIGHT KINK. AFTER SERVICE REPAIRS, ALL VERIFICATION TESTING PASSED WITHIN THE INSTRUMENT'S SPECIFICATIONS AND ASSAY QC PASSED WITHIN THE LABORATORY'S ESTABLISHED RANGES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A LOWER THAN EXPECTED TROPONIN I (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT ON THE ACCESS 2 PORTION OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE LOWER RESULT WAS QUESTIONED BY THE LABORATORIAN AS THE PREVIOUS RESULT FOR THIS SAMPLE WAS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF. THUS, THE SAMPLE IN QUESTION WAS RE-ANALYZED AND THE RESULT WAS AGAIN ABOVE THE AMI CUT-OFF. ANOTHER SAMPLE WAS DRAWN FROM THE PATIENT AND ANALYZED IN DUPLICATE. BOTH RESULTS WERE REPRODUCIBLE AND ELEVATED. THE LOWER RESULT WITHIN THE RISK STRATIFICATION RANGE WAS NOT RELEASED FROM THE LABORATORY. THERE WAS NO CHANGE TO OR IMPACT ON PATIENT TREATMENT REPORTED IN CONJUNCTION WITH THIS EVENT. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333079 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 65 YR