BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2695111 · Received August 13, 2012

    Report

    Report Number
    2122870-2012-01673
    Event Type
    Malfunction
    Date Received
    August 13, 2012
    Date of Event
    July 19, 2012
    Report Date
    July 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    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

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) PERFORMED SEVERAL REPAIRS TO THE INSTRUMENT HARDWARE INCLUDING REPLACING THE INCUBATOR BELT AND REPLACEMENTS OF OTHER WASH WHEEL COMPONENTS. UPON COMPLETION OF THE REPAIRS THE FSE VERIFIED HARDWARE PERFORMANCE AND THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. THE CAUSE OF THIS EVENT IS CURRENTLY UNKNOWN AND COULD NOT BE DETERMINED FROM THE SUPPLIED DOCUMENTATION FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUS ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) THRESHOLD, WAS GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT UPON REPEAT TESTING ON THE SAME AND ALTERNATE INSTRUMENTS, THE REPEAT RESULTS WERE ALL LOWER, WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY AND CONSIDERED VALID. THE INITIAL, ERRONEOUS ACCUTNI RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND ALTHOUGH THE PATIENT WAS TRANSFERRED FROM THE EMERGENCY ROOM INTO AN AMBULANCE IN PREPARATION FOR TRANSPORT TO AN ALTERNATE FACILITY, THE TRANSFER WAS CANCELLED UPON GENERATION OF THE VALID RESULTS. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE WAS A FULL VOLUME, LITHIUM HEPARIN SAMPLE WHICH WAS REGARDED AS NORMAL IN APPEARANCE WITH NO SAMPLE INTEGRITY CONCERNS. THE SAMPLE WAS CENTRIFUGED FOR SIX MINUTES AT THREE THOUSAND REVOLUTIONS PER MINUTE PRIOR TO TESTING. THE REAGENT LOT AND CALIBRATOR LOT ASSOCIATED WITH THIS EVENT WERE 220592 AND 121451 RESPECTIVELY NO OTHER ASSAYS WERE QUESTIONED AS PART OF THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT ASSAY PERFORMANCE DATA INDICATED THAT A SYSTEM CHECK PERFORMED PRIOR TO THE EVENT MET INSTRUMENT SPECIFICATIONS WITH ACCEPTABLE PERCENT COEFFICIENTS OF VARIATION (%CVS). THE CUSTOMER REPORTED QUALITY CONTROL RESULTS WERE PERFORMING WITHIN THEIR ESTABLISHED RANGES ON THE DATE OF THE EVENT. THE CUSTOMER INDICATED THAT THEY HAD PREVIOUSLY EXPERIENCED NON REPRODUCIBLE ACCUTNI RESULTS, HOWEVER, FURTHER DETAILS WERE NOT PROVIDED AS PART OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR