BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2092040 · Received May 18, 2011

    Report

    Report Number
    2122870-2011-01421
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER NORMAL TROUBLESHOOTING WITH CUSTOMER TECHNICAL SERVICE, SERVICE WAS DISPATCHED. THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE (B)(6) 2011 AND FOUND THE PIPETTOR TIP WAS WORN AND THE HIGH ULTRASONIC VOLTAGE WAS LOW. AFTER THE FSE PERFORMED REPAIRS, SYSTEM PRECISION CHECKS AND QUALITY CONTROL RESULTS WERE FOUND TO BE SATISFACTORY. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 THEY WERE RECOVERING ERRATIC LEVEL 1 QUALITY CONTROL RESULTS ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ACCESS ESTRADIOL. THE CUSTOMER NOTED NO ISSUES WITH ANY OTHER ANALYTES. THE CUSTOMER DID NOT REPORT ANY ERRONEOUS RESULTS REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT. HOWEVER, THE POTENTIAL FOR ERRONEOUS BUT BELIEVABLE RESULTS DOES EXIST FOR ALL ASSAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ESTRADIOL