BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2812827 · Received October 31, 2012

    Report

    Report Number
    2122870-2012-01860
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED A PASSING HIGH SENSITIVITY SYSTEM CHECK WITHOUT ANY ADDITIONAL SERVICE TO THE INSTRUMENT. NO HARDWARE ISSUES WERE NOTED. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER REPORTED QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES ON THE DAY OF EVENT AND CONFIRMED THERE WERE NO SYSTEM ERRORS, IN THE EVENT LOG, AT THE TIME OF ANALYSIS. THE CUSTOMER REPORTED THE PATIENT SAMPLE WAS COLLECTED INTO A 5.0 ML BECTON DICKINSON SERUM SEPARATOR TUBE AND CENTRIFUGED AT 5,100 RPM (REVOLUTIONS PER MINUTE) FOR FIVE MINUTES IN A STAT SPIN CENTRIFUGE AND PROCESSED THROUGH THE ANALYZER'S CLOSED TUBE ALIQUOTTER (CTA). THE CUSTOMER NOTED THE SAMPLE WAS COLLECTED ON THE UNIT INTO THE SERUM SEPARATOR TUBE; ALL ADDITIONAL TROPONIN I RESULTS WERE OBTAINED USING A LITHIUM HEPARIN PLASMA SEPARATOR TUBE. THE SAMPLE WAS COLLECTED AT 23:40 AND RECEIVED IN THE LABORATORY AT 23:58; THE RESULT WAS OBTAINED AT 00:22. IT WAS NOTED THE TECHNOLOGIST DID NOT ALLOW THE SAMPLE TO CLOT FOR THE TIME RECOMMENDED BY THE TUBE MANUFACTURER (30 MINUTES) PRIOR TO PROCESSING THE SAMPLE. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED A FALSE POSITIVE TROPONIN I (ACCESS ACCUTNI) RESULT, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR ONE PATIENT, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. SUBSEQUENT ANALYSIS OF THE PATIENT SAMPLE, ON THE SAME INSTRUMENT, RECOVERED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE OF THE ASSAY. THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. AS A RESULT, THE PATIENT BEGAN AN UNSPECIFIED TREATMENT FOR MYOCARDIAL INFARCTION. AN AMENDED REPORT WAS ISSUED TO THE PHYSICIAN. THE CUSTOMER INDICATED THE PATIENT APPEARED TO BE PRESENTED WITH POSSIBLE CARDIAC OR ALLERGIC REACTION FEATURES. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    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 Other