BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 4201091 · Received October 27, 2014

    Report

    Report Number
    2122870-2014-00745
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 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
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM AND IDENTIFIED A FLUID LEAK AT THE SUBSTRATE FLUIDICS LINE DUE TO A LOOSE FITTING. THE FSE TIGHTENED THE LOOSE FITTING AND RESOLVED THE ISSUE. 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 LINE FITTING. A DEFINITIVE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SUBSTRATE BOTTLE EMPTY WITH TESTS REMAINING AND SAMPLE COUNTS OUTSIDE LIMITS SYSTEM ERRORS INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682092 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1