BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2821570 · Received November 6, 2012

    Report

    Report Number
    2122870-2012-01873
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN LITHIUM HEPARIN PLASMA TUBES. PATIENT 3 SAMPLE WAS A FULL DRAW AND RUN DIRECTLY FROM THE PRIMARY TUBE. PER CUSTOMER, THEY INVERT THE PLASMA SAMPLES 8-10 TIMES AFTER THEY ARE DRAWN AND THEY HAVE GONE OVER SAMPLE HANDLING IN THE PAST WITH BEC HOTLINE. THE CUSTOMER APPEARED TO BE USING PROPER SAMPLE HANDLING TECHNIQUES. QC WAS RECOVERING WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DAYS THE EVENTS OCCURRED. SYSTEM CHECKS WERE PASSING WITHIN INSTRUMENT SPECIFICATIONS ON (B)(6) 2012 HOWEVER, THE SYSTEM CHECK ON THE (B)(6) HAD TO BE REPEATED AFTER THE %CV (COEFFICIENT OF VARIATION) OF THE UNWASHED PORTION WAS FALLING OUTSIDE OF THE SPECIFICATION. A FIELD SERVICE ENGINEER (FSE) WENT ON SITE THE DAY OF THE EVENT. FSE OBSERVED THAT ULTRASONIC SETTINGS REQUIRED ADJUSTMENT FROM 185V TO 197V AND FROM 6.7V TO 5.98V. FSE PERFORMED THE ADJUSTMENTS AND THEN VERIFIED INSTRUMENT ALIGNMENTS, VOLTAGES, AND TEMPERATURES. FSE ALSO PERFORMED A PRECISION STUDY ON ALL THREE LEVELS OF ACCUTNI QC WITH ACCEPTABLE RESULTS. IMPROPER ULTRASONIC SETTINGS CAN IMPACT PARTICLE MIXING WITHIN REAGENT PACKS, LEVEL SENSING, AND SAMPLE MIXING WITHIN RVS (REACTION VESSELS), HOWEVER, THE FSE DID NOT PROVIDE ANY DATA WHICH DEMONSTRATED THAT THE ULTRASONIC SETTINGS WERE CAUSING ACCUTNI RESULT REPRODUCIBILITY ISSUES. THE CAUSE OF THIS EVENT IS UNKNOWN. INSUFFICIENT EVIDENCE WAS SUPPLIED TO DETERMINE THE CAUSE OF THIS EVENT. MDR#2122870-2012-01871 DOCUMENTS THE RESULTS GENERATED ON (B)(6) 2012 (FOR PATIENT 1 OF 3) AND MDR#2122870-2012-01872 DOCUMENTS THE RESULTS GENERATED ON (B)(6) 2012 (FOR PATIENT 2 OF 3).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THREE INCIDENTS OF NON-REPRODUCIBLE TROPONIN (ACCUTNI) RESULTS GENERATED BY THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR THREE DIFFERENT PATIENTS. REPEAT TESTING PRODUCED ERRATIC RESULTS IN A DIFFERENT CLINICAL CATEGORY FOR EACH PATIENT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RUNS ALL TROPONIN RESULTS IN DUPLICATE. THERE WAS NO AFFECT TO PATIENTS WITH REGARD TO THIS EVENT. THIS REPORT DOCUMENTS THE RESULTS GENERATED ON (B)(6) 2012 (FOR PATIENT 3 OF 3). SEPARATE REPORTS HAVE BEEN SUBMITTED DOCUMENTING THE RUNS ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1