BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4327441 · Received December 12, 2014

    Report

    Report Number
    2122870-2014-00811
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 14, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE AGE, SEX, OR WEIGHT FOR ANY OF THE PATIENTS. CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED CUSTOMER TO PERFORM SYSTEM CHECK AND 15-REP PRECISION RUN. SYSTEM CHECK PASSED, BUT THE PRECISION RUN FAILED. SERVICE WAS DISPATCHED. THE FIELD SERVICE ENGINEER (FSE) NOTED MICROBUBBLES IN THE WASH PUMP. THE FSE REPLACED THE WASH VALVE STATOR, ROTOR, THRUST BEARING, SEALS AND BELT. THE FSE PRIMED THE SYSTEM 30 TIMES AND DID NOT NOTE THE PRESENCE OF BUBBLES. THE FSE RAN A PASSING SYSTEM CHECK AND 20 REPLICATE PRECISION RUN. THE REPLACEMENT OF THE WASH VALVE ROTOR AND WASH VALVE STATOR CORRECTED THE PRESENCE OF MICROBUBBLES IN THE WASH PUMP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE, ELEVATED, TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR MULTIPLE PATIENTS ON THE ACCESS 2 IMMUNOASSAY SYSTEM PORTION OF THE LABORATORY'S UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (SERIAL NO. 800534) . IT WAS NOTED THAT LEVEL 1 QC (QUALITY CONTROL), CALIBRATION CURVES, AND PRECISION RUNS WERE ERRATIC AND OUT OF SPECIFICATION AT THE TIME OF THE EVENT. ON THE DAY OF THIS EVENT, THE INSTRUMENT FAILED ACCUTNI+3 CALIBRATION TWICE BEFORE PASSING ON THE THIRD ATTEMPT. SYSTEM CHECK PASSED PRIOR TO THE EVENT. CUSTOMER VERBALLY PROVIDED RESULTS FOR ONE PATIENT SAMPLE. THE CUSTOMER ALLEGED THAT 7 TO 10 PATIENT SAMPLES PRODUCED NONREPRODUCIBLE ACCUTNI+3 RESULTS AND WERE RERUN, BUT DID NOT PROVIDE ACTUAL PATIENT RESULTS. PER CUSTOMER POLICY ALL ACCUTNI+3 RESULTS ARE RUN IN DUPLICATE AND REPEATS ARE CONDUCTED WHEN SAMPLE RESULTS DO NOT MATCH. THE CUSTOMER INDICATED THAT NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. THE SAMPLES WERE LITHIUM HEPARIN PLASMA AND NO SAMPLE INTEGRITY ISSUES WERE REPORTED. THE SAMPLES WERE CENTRIFUGED AT AMBIENT TEMPERATURE FOR 8 MINUTES AT 3500 RPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808896 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1