BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3914273 · Received July 3, 2014

    Report

    Report Number
    2122870-2014-00447
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. A SYSTEM CHECK WAS PERFORMED AND DID NOT PASS SERVICE SPECIFICATIONS. THE FSE CHANGED THE PERI-PUMP TUBING AND REBUILT THE WASH PUMP. ANOTHER SYSTEM CHECK WAS PERFORMED AND STILL FAILED SERVICE SPECIFICATIONS. THE FSE ORDERED PARTS AND RETURNED THE FOLLOWING DAY TO REMOVE THE ANALYTICAL MODULE AND REPLACE THE PINCH SPRINGS, PIVOT PINCH ROLLERS, PULLEYS, BEARINGS, E-CLIPS, AND ASPIRATE PROBES; THE FSE ALSO ADJUSTED THE ULTRASONIC TRANSDUCER TEMPERATURE AND RV VOLTAGE TO SPECIFICATIONS. A SYSTEM CHECK PASSED SERVICE SPECIFICATIONS, BUT A HIGH SENSITIVITY SYSTEM CHECK DID NOT. THE FSE NOTED DRIED WASH BUFFER BUILD UP ON THE MOTOR UNDER THE WASH VALVE AND AROUND THE FLUIDICS MANIFOLD. THE FSE REPLACED THE FLUIDICS MANIFOLD, PERI-PUMP TUBING, AND ASPIRATE PROBES AND REBUILT THE PRECISION PUMP. TRANSDUCER TEMPERATURE AND VOLTAGE WERE ADJUSTED. THE FSE RAN A HIGH SENSITIVITY SYSTEM CHECK, CALIBRATION, QC AND PRECISION RUN WITH PASSING RESULTS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ACCESS 2 IMMUNOASSAY SYSTEM OF A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED NON-REPRODUCIBLE TROPONIN I (ACCUTNI+3) RESULTS. THE CUSTOMER STATED THAT FALSELY ELEVATED ACCUTNI+3 RESULTS WERE GENERATED FOR TWO PATIENTS ON AN INITIAL RUN AND REPORTED OUT OF THE LABORATORY; THE CUSTOMER IS NOT AWARE OF CHANGE TO OR IMPACT TO PATIENT TREATMENT. THE PATIENT SAMPLES WERE RETESTED ON AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM IN THE LABORATORY AND LOWER ACCUTNI+3 RESULTS WERE GENERATED. THE CUSTOMER NOTED THAT ONE QUALITY CONTROL (QC) RESULT WAS OUT OF RANGE ON THE DATE OF THIS EVENT, BUT ACCUTNI+3 WAS NOT AFFECTED. INSTRUMENT DATA SUCH AS QUALITY CONTROL (QC) RESULTS, CALIBRATION, AND SYSTEM DATA WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391534 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1