BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3974313 · Received August 1, 2014

    Report

    Report Number
    2122870-2014-00554
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED SUBSTRATE DECONTAMINATION AND REPLACED THE SUBSTRATE PROBE BUT THE ISSUE REMAINED. THE FSE THEN REPLACED THE SUBSTRATE PUMP AND NOTED SUBSEQUENT SYSTEM CHECK PASSED ALL SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE SUBSTRATE PUMP. A DEFINITIVE ROOT CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILED SYSTEM CHECKS FOR THE WASHED MEAN PORTION AND HIGH COEFFICIENT OF VARIATION (%CV) INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER PERFORMED SYSTEM TROUBLESHOOTING AND NOTED THERE WERE NO SYSTEM ISSUES. BECKMAN COULTER GUIDED THE CUSTOMER THROUGH REPLACING THE PERISTALTIC PUMP TUBING BUT THE ISSUE REMAINED. THE CUSTOMER STATED PATIENT SAMPLES WERE NOT ANALYZED AT THE TIME OF THE EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS 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
    450019 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1