BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2893900 · Received January 3, 2013

    Report

    Report Number
    2122870-2012-02044
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) PERFORMED A MIXER TEST WHICH PASSED WITHIN SPECIFICATION. SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK PASSED WITH ALL PARAMETERS AND WITHIN SPECIFICATION. THE FSE VERIFIED QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER'S ESTABLISHED LIMITS AND COMPLETED THE MIXER PULLEY MODIFICATION. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION RANGE, FOR ONE PATIENT, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT ANALYSIS OF THE PATIENT SAMPLE, ON THE SAME ANALYZER, RECOVERED A LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS RELEASED OUT OF THE LABORATORY, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE RESULT. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND ALSO PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER STATED THE SAMPLE WAS CLEAR AND APPEARED NORMAL. THE SAMPLE WAS ANALYZED IN A LITHIUM HEPARIN, 13/75 MM TUBE AND CENTRIFUGED AT 3,500 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES AT ROOM TEMPERATURE. QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS PRIOR TO AND ON THE DAY OF THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2419 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization