BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3003018 · Received March 13, 2013

    Report

    Report Number
    2122870-2013-00288
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BECKMAN COULTER
    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

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE INCUBATOR BELT WAS NOISY AND PROACTIVELY REPLACED THE BELT AND CLEANED THE INCUBATOR BELT TRACK. THE FSE ALSO CLEANED THE WASH WHEEL AND REPLACED THE MIXER PULLEYS AND MIXER BELT. THE FSE VERIFIED ALL BELT AND PIPETTOR ALIGNMENTS; NO ISSUES WERE NOTED. THE FSE VERIFIED ULTRASONICS AND THE LUMINOMETER; NO ISSUES WERE NOTED. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK BOTH OF WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. THE CUSTOMER INDICATED ALL THREE LEVELS OF QUALITY CONTROL (QC) WERE PERFORMING WITHIN THE LABORATORY'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. A ROUTINE SYSTEM CHECK, PERFORMED ON THE DAY OF THE EVENT, ALSO PASSED WITHIN INSTRUMENT SPECIFICATION. PATIENT SAMPLES WERE COLLECTED IN 5 ML BECTON DICKINSON (BD) LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00287.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION, FOR THREE PATIENTS, ON SEPARATE DAYS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT REFLEX ANALYSES OF THE PATIENTS' SAMPLES, ON THE SAME INSTRUMENT, RECOVERED LOWER RESULTS EITHER WITHIN THE NORMAL REFERENCE RANGE OR WITHIN THE RISK STRATIFICATION. THE INITIAL ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY PRIOR TO COMPLETING REFLEX TESTING. ALL CRITICAL VALUES ARE AUTOMATICALLY REFLEXED AND AMENDED REPORTS WERE ISSUED. THE PHYSICIANS WERE NOTIFIED WHEN THE REFLEX RESULTS WERE NOT CRITICAL. AT PRESENT, THE CUSTOMER DOES NOT KNOW IF PATIENT TREATMENT WAS IMPACTED. THERE HAS BEEN NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT TWO OF TWO REFERENCING THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105601 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1