BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3133905 · Received May 29, 2013

    Report

    Report Number
    2122870-2013-00493
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    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

    THE FIELD SERVICE ENGINEER (FSE NOTED THAT THE WASHED PORTION OF SYSTEM CHECK WAS OUT OF SPECIFICATIONS. THE FSE REPLACED THE SUBSTRATE PROBE, ASPIRATE PROBES, AND WASTE TUBING TO RESOLVE THE ISSUE. A PATIENT CORRELATION WAS PERFORMED BETWEEN THE TWO INSTRUMENTS. RECOVERY ON THE SUSPECT INSTRUMENT APPEARED APPROXIMATELY 18% HIGHER THAN ON THE ALTERNATE INSTRUMENT (DATA NOT SUPPLIED). THE FSE THEN DISCOVERED A BROKEN WASH WHEEL BEARING AND REPLACED THE BEARING AND RESOLVED THE ISSUE. 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. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00494.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRATIC TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION, FOR ONE PATIENT, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. SAMPLE REANALYSIS, ON AN ALTERNATE ACCESS 2 SYSTEM, RECOVERED A LOWER RESULT WITHIN THE RISK STRATIFICATION RANGE. THE ORIGINAL RESULT WAS RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE LABORATORY HAS A PROTOCOL TO VALIDATE ALL TROPONIN I POSITIVE RESULTS GREATER THAN 0.1 NG/ML. THE CUSTOMER DEFINES RESULTS AS DISCREPANT IF THE DIFFERENCE IS GREATER THAN 10%. THE CUSTOMER INDICATED THE INSTRUMENT HAD BEEN SERVICED ON (B)(6) 2013 AND HAD HARDWARE THERMAL MODIFICATION PERFORMED INCLUDING REPLACEMENT OF A FAN. THE CUSTOMER INDICATED SYSTEMS CHECKS AND QC HAD BEEN PASSING ON THE SUSPECT AND ALTERNATE INSTRUMENTS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235745 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1