BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3962238 · Received July 28, 2014

    Report

    Report Number
    2122870-2014-00548
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE MIXER MOTOR SPEED AND REPLACED THE ULTRASONICS PRINTED CIRCUIT BOARD (PCB). THE FSE PERFORMED A SUCCESSFUL SYSTEM CHECK BUT NOTED QUALITY CONTROL (QC) VALUES WERE CLOSE TO THE MEAN. THE FSE REMOVED, INSPECTED, AND CLEANED THE WASH CAROUSEL. THE FSE REPLACED THE BEARINGS, MIXER BELT, PULLEYS AND IDLERS, INCUBATOR BELT, PERISTALTIC PUMP TUBING, WASH AND PRECISION PUMP BELTS AND SEALS, AND THE PIPETTOR TIP. THE FSE INSPECTED AND CLEANED THE INCUBATOR TRACK AND REMOVED AND CLEANED THE WASH AND PRECISION VALVES. THE FSE CALIBRATED THE ULTRASONICS, ADJUSTED THE MIXER BELT SPEED, FITTED THE INCUBATOR BELT AND CLIPS, AND CALIBRATED AND ALIGNED THE INCUBATOR BELT. THE FSE PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY (HS) SYSTEM CHECK WHICH RECOVERED WITHIN SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, SYSTEM HARDWARE IS THE LIKELY CAUSE OF THE EVENT AS REPAIRS AND ADJUSTMENTS RESOLVED THE REPORTED ISSUE. HOWEVER, A SPECIFIC HARDWARE COMPONENT WAS NOT IDENTIFIED AS THE SINGULAR CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED TROPONIN I (ACCESS ACCUTNI) IMPRECISION ON QUALITY CONTROL (QC) AND PATIENT RESULTS INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER NOTED LOW AND ERRATIC PATIENT RESULTS, BELOW THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT. THE CUSTOMER STATED ALL PATIENT SAMPLES WERE REANALYZED ON THE ALTERNATE ACCESS 2 SYSTEM BEFORE RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. IN ADDITION, THE CUSTOMER NOTED SYSTEM CHECK WAS NOT WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SERVICE WAS REQUESTED AND A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439469 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1