BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3022238 · Received March 26, 2013

    Report

    Report Number
    2122870-2013-00324
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TO THE FIELD SERVICE ENGINEER (FSE) THERE WAS AN INCUBATOR BELT JAM DUE TO A VESSEL FALLING AND GETTING JAMMED. THE FSE NOTED THE INCUBATOR BELT WAS STRETCHED AND REMOVED THE INCUBATOR BELT AND CLEANED THE TRACK. THE FSE REMOVED AND CLEANED THE MIXER PULLEYS. THE FSE PERFORMED PIPETTOR AND INCUBATOR BELT ALIGNMENTS, AND COMPLETED A SUCCESSFUL SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION, FOR ONE PATIENT, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATORS. AN INITIAL RESULT OF 0.12 NG/ML WAS OBTAINED. SUBSEQUENT ANALYSIS OF THE PATIENT'S SAMPLE, ON THE SAME INSTRUMENT AND APPROXIMATELY THIRTY MINUTES AFTER THE INITIAL RESULT, RECOVERED A LOWER VALUE OF 0.04 NG/ML. THE PATIENT'S SAMPLE WAS ALSO ANALYZED ON AN ALTERNATE ACCESS SYSTEM AND PRODUCED A RESULT OF 0.04 NG/ML, WHICH WAS REPORTED TO THE HOSPITAL. THE ERRONEOUS RESULT WAS NOT RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE SAMPLE WAS COLLECTED IN A 13X75 MM LITHIUM HEPARIN BECTON DICKINSON (BD) TUBE WITH GEL BARRIER AND CENTRIFUGED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES. THE SAMPLE WAS COLLECTED BY THE EMERGENCY ROOM (ER) NURSE. SYSTEM CHECK, PERFORMED PRIOR TO AND AFTER THE EVENT, WAS WITHIN SPECIFICATIONS. QUALITY CONTROL (QC), PERFORMED ON (B)(4) 2012, RECOVERED HIGH FOR THE LOW CONTROL. QC PERFORMED AFTER THE EVENT WAS CLOSER TO THE MEAN VALUE. ALL THREE LEVELS OF QC WERE WITHIN SPECIFICATIONS ON THE DAY OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123778 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1