BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 3850023 · Received June 4, 2014

    Report

    Report Number
    2122870-2014-00420
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED EVIDENCE OF AN UNKNOWN FLUID LEAK AT THE BOTTOM OF THE SUBSTRATE PUMP. NO INJURY FROM THE LEAK WAS REPORTED. THE FSE NOTED DRIED SUBSTRATE BUILDUP AT THE HEXAGONAL PISTON GUIDE CAP THAT RETAINS THE SUBSTRATE PISTON. THE FSE ALSO NOTED A SMALL FRACTURE IN THE PUMP HOUSING AND REPLACED THE COMPLETE SUBSTRATE PUMP TO RESOLVE THE ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN. IT IS UNCERTAIN WHETHER THE FLUID LEAK WAS CAUSED BY AN UNDER-TORQUED CAP OR BY THE SMALL FRACTURE IN THE PUMP HOUSING. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE STATED THE CUSTOMER REPORTED SAMPLE COUNTS OUTSIDE LIMITS SYSTEM ERROR INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED NO ERRONEOUS PATIENT RESULTS WERE 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
    326160 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1