BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2915870 · Received January 15, 2013

    Report

    Report Number
    2122870-2013-00023
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE MIXER SPEED, LUMINOMETER VOLTAGE, VACUUM SYSTEM AND INSTRUMENT TEMPERATURES WERE ALL WITHIN SPECIFICATION. THE FSE DISCOVERED A DEFECTIVE O-RING BETWEEN THE PRECISION PUMP AND FLUIDICS MANIFOLD, WHICH WAS ALLOWING AIR TO ENTER THE PUMP. THE FSE REPLACED THE O-RING. THE FSE NOTED THE INCUBATOR BELT WAS NOISY AND REPLACED THE INCUBATOR BELT AND VESSEL HOLDERS PROACTIVELY. THE FSE COMPLETED PREVENTIVE MAINTENANCE (PM), MIXER PULLEY AND PERISTALTIC PUMP MODIFICATIONS. THE FSE VERIFIED ALIGNMENTS WERE WITHIN SPECIFICATION. THE FSE PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN SPECIFICATION. THE FSE VERIFIED TROPONIN I QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. THE FSE PERFORMED A 50-REPLICATE TROPONIN I PRECISION RUN, WHICH PASSED WITHIN SPECIFICATION. SERVICE ACTIVITY PERFORMED WAS VERIFIED AND MET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00022.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR MULTIPLE PATIENTS ON SEPARATE DAYS, AND QUALITY CONTROL FAILED INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT SAMPLES WERE REANALYZED AND RECOVERED HIGHER TROPONIN I RESULTS. FURTHER REVIEW OF THE CUSTOMER-SUPPLIED DATA ALSO INDICATES IMPRECISE RESULTS ON CREATINE KINASE-MB (CK-MB). THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT TWO OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21935 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1