BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2932021 · Received January 28, 2013

    Report

    Report Number
    2122870-2013-00046
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE FOUND EXCESSIVE FLUID IN THE PROCESSED REACTION VESSELS (RVS) WHICH WAS ATTRIBUTED TO A HOLE FOUND IN THE ASPIRATE TUBING FOR PROBE #3.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOTICING ACCUTNI PATIENT RESULTS RECOVERING HIGHER ON THE ACCESS 2 IMMUNOASSAY ANALYZER. EXACT PATIENT VALUES WERE NOT PROVIDED TO BECKMAN COULTER (BEC). THE CUSTOMER THEN PERFORMED QUALITY CONTROL (QC) WHICH FAILED. BEC CUSTOMER TECHNICAL SUPPORT REQUESTED PATIENT RESULTS, QC CALIBRATION DATA AND MAINTENANCE INFORMATION FOR THE REPORTED EVENT. THE DATA HAD BEEN SENT TO AN OFF-SITE STORAGE FACILITY AND WAS UNAVAILABLE TO BEC FOR ANALYSIS OF THE EVENT. BEC FIELD SERVICE ENGINEER (FSE) ASSESSED THE ANALYZER AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37368 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1