BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3191748 · Received June 26, 2013

    Report

    Report Number
    2122870-2013-00577
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE IDENTIFIED SEVERAL HARDWARE ISSUES INCLUDING PIPETTOR AND WASH ARM MISALIGNMENT, INCORRECT ULTRASONIC TRANSDUCER VOLTAGE, AND A NOISY INCUBATOR BELT. THE FSE COMPLETED THE REPAIRS AND RETURNED THE INSTRUMENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS TROPONIN I (ACCUTNI) RESULTS GENERATED ON THE ACCESS 2 FOR ONE PATIENT. THE INITIAL RESULT WAS WITHIN THE RISK STRATIFICATION RANGE. THE SAMPLE WAS AUTOMATICALLY REPEATED DUE TO A REFLEX CONDITION AND ALSO RECOVERED WITHIN THE RISK STARTIFICATION RANGE, BUT WITH UNACCEPTABLE PRECISION. THE CUSTOMER QUESTIONED THE RESULTS DUE TO POOR PRECISION AND BECAUSE A DIFFERENT SAMPLE FROM THE PATIENT ANALYZED THE PREVIOUS DAY RECOVERED WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER RE-CENTRIFUGED TEH SAMPLE AND REPEATED IT TWICE. BOTH RESULTS RECOVERED WITHIN THE NORMAL REFERENCE RANGE. THE PATIENT WAS REDRAWN AND ANALYZED IN TRIPLICATE. ALL OF THESE RESULTS ALSO RECOVERED WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER STATED THE ERRONEOUS INITIAL RESULT WAS REPORTED OUT OF THE LABORATORY. BASED ON THE RESULT, THE PATIENT, WHO WAS ALREADY HOSPITALIZED AS AN IN-PATIENT, WAS TRANSFERRED TO THE CARDIAC CARE UNIT. THE CUSTOMER DID NOT KNOW IF ANY PROCEDURES WERE PERFORMED ON THE PATIENT BEFORE CORRECTED RESULTS WERE PROVIDED TO THE PHYSICIAN. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) DATA WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS BEFORE THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290217 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1