BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3180889 · Received June 20, 2013

    Report

    Report Number
    2122870-2013-00557
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO PERFORM WASH PUMP REPAIRS AFTER OBSERVING DISPENSE PROBE #5 WAS NOT DISPENSING ANY WASH BUFFER. THE FSE REPLACED THE WASH VALVE SEAL, ROTOR, AND STATOR. THE FSE ATTEMPTED TO RESEAT THE PUMP MOTOR DRIVER BOARD AND MOTION CONTROL BOARD WITH NO RESOLUTION. THE FSE ORDERED A REPLACEMENT PUMP AND INSTALLED THE NEW WASH PUMP TO RESOLVE THE ISSUE. SERVICE ACTIVITY WAS VERIFIED TO MEET SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00556.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE, ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR FIVE PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. SUBSEQUENT TESTING OF THE PATIENTS¿ SAMPLES, ON THE SAME INSTRUMENT, RECOVERED LOWER RESULTS. THE CUSTOMER STATED ELEVATED TROPONIN I RESULTS ARE RETESTED PER LABORATORY PROTOCOL. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED PATIENT #1 HAD A STRESS TEST CANCELLED BASED ON THE RESULT; THERE WAS NO IMPACT TO PATIENT CARE. THE PATIENTS¿ SAMPLES WERE COLLECTED IN 12X75 MM GREEN TOP TUBES AND CENTRIFUGED IN THE PRIMARY TUBES FOR TEN MINUTES. THE CUSTOMER NOTED PATIENT #1'S SAMPLE APPEARED SLIGHTLY LYPEMIC, AND RE-CENTRIFUGED AND ALIQUOTED FOR REANALYSIS. QUALITY CONTROL (QC), PERFORMED PRIOR TO THE ERRONEOUS RESULTS, SHOWED LEVELS 2 AND 3 WERE WITHIN RANGE, BUT LEVEL 1 QC WAS OUT OF SPECIFICATIONS. SYSTEM CHECK, PERFORMED ON (B)(6) 2013, PASSED WITHIN THE ACCEPTABLE RANGE BUT NOT WITHIN THE BEST GUIDELINES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THIS IS REPORT TWO OF TWO REFERENCING PATIENT #5 ON THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279778 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1