BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2962677 · Received February 14, 2013

    Report

    Report Number
    2122870-2013-00122
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VERIFIED HARDWARE PERFORMANCE AND NOTED NO SYSTEM MALFUNCTIONS. THE FSE ANALYZED FOUR PATIENT SAMPLES TO INVESTIGATE SAMPLE PROCESSING. THE SAMPLES WERE CENTRIFUGED AT 3,600 RPM (ROTATIONS PER MINUTE) FOR SEVEN MINUTES, TESTED THROUGH THE ANALYZER'S CLOSED TUBE ALIQUOTTER (CTA), AND LOADED DIRECTLY ONTO THE ORIGINAL AND THE ALTERNATE UNICEL DXC 600I ANALYZERS. ALL TROPONIN I AND CREATINE KINASE-MB (CK-MB) RESULTS WERE REPRODUCIBLE AND HAD GOOD PRECISION BETWEEN BOTH ANALYZERS. A HIGH SENSITIVITY SYSTEM CHECK AND ALL LEVELS OF QUALITY CONTROL (QC) PASSED WITHIN THE ASSAY, INSTRUMENT, AND LABORATORY SPECIFICATIONS. THE FSE RECOMMENDED CENTRIFUGATION SPEED AND TIME CONFIGURATION ADJUSTMENTS DUE TO THE INSUFFICIENCY TO PRODUCE QUALITY SAMPLES. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. THE CUSTOMER STATED THE PATIENT SAMPLES WERE COLLECTED, CENTRIFUGED, AND ANALYZED IMMEDIATELY AT ROOM TEMPERATURE. THE SAMPLES WERE COLLECTED IN 13X100MM BECTON DICKINSON (BD) LITHIUM HEPARIN PLASMA TUBES AND CENTRIFUGED IN A STAT SPIN CENTRIFUGE FOR THREE MINUTES, LOADED THROUGH THE CLOSED TUBE ALIQUOTTER (CTA). QUALITY CONTROL (QC) IS PERFORMED EVERY 24 HOURS AND WAS WITHIN SPECIFICATION ON 01/19/2013. QC WAS NOT PERFORMED ON THE DAY OF THE EVENT. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2013-00121, 2122870-2013-00122, 2122870-2013-00123, 2122870-2013-00124.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT AND WITHIN THE RISK STRATIFICATION, FOR FOUR PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM USED IN CONJUNCTION WITH ACCESS ACCUTNI AND ACCESS CREATINE KINASE-MB (CK-MB) ASSAYS. ADDITIONAL REVIEW OF THE CUSTOMER-SUPPLIED DATA ALSO REVEALED DISCREPANT CK-MB RESULTS FOR THE FOUR PATIENTS - TWO VALUES WERE ABOVE THE NORMAL REFERENCE RANGE. SUBSEQUENT ANALYSIS OF THE PATIENT'S SAMPLES, ON AN ALTERNATE UNICEL DXC 600I SYSTEM, PRIMARILY RECOVERED LOWER RESULTS, WITHIN THE NORMAL REFERENCE RANGE, FOR TROPONIN I AND CK-MB. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY, AND THE PATIENTS WERE ADMITTED TO THE HOSPITAL BASED ON THE ELEVATED VALUES. THE CUSTOMER STATED IT IS UNKNOWN IF ALL FOUR PATIENTS WERE ADMITTED TO THE HOSPITAL OR IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENTS. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT TWO OF FOUR, REFERENCING PATIENT #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65164 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 Hospitalization