BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3081666 · Received April 29, 2013

    Report

    Report Number
    2122870-2013-00382
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE SUBSTRATE TUBE FITTING, TO THE BLACK ASSEMBLY, WAS LOOSE AND LEAKING FLUID. THE FSE TIGHTENED THE FITTING AND PRIMED THE SUBSTRATE TO RESOLVE THE FLUID LEAK ISSUE. QUALITY CONTROL (QC) WAS PERFORMED TO VERIFY SYSTEM OPERATION. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INSTRUMENT WAS USING MORE SUBSTRATE THAN NORMAL INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER HAD RECENTLY MOVED THE INSTRUMENT. DURING TROUBLESHOOTING, THE CUSTOMER DISCOVERED A PUDDLE OF SUBSTRATE SOLUTION UNDER THE INSTRUMENT, NEAR THE TUBING CONNECTION. THE LABORATORY HAS A POLICY FOR SPILL CLEANUP IN PLACE. THE CUSTOMER DISCONTINUED USE OF THE INSTRUMENT AND REQUESTED SERVICE. THE CUSTOMER DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185610 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1