BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2073406 · Received May 1, 2011

    Report

    Report Number
    2122870-2011-01199
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    May 8, 2009
    Report Date
    May 8, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE AND CENTRIFUGATION DATA WAS NOT SUPPLIED. PER CUSTOMER, QC RESULTED WITHIN SPECIFICATIONS. A SYSTEM CHECK PERFORMED ON (B)(4) 2009 MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING WITH THE CUSTOMER ON (B)(6) 2009: FSE HAD THE CUSTOMER RECALIBRATE ACCUTNI AND REPEAT THE PATIENT SAMPLE IN QUESTION. FSE NOTED THAT THE ACCUTNI RESULTS FOR THE PATIENT OBTAINED PRIOR TO AND AFTER RECALIBRATION RECOVERED SIMILAR. THE PHYSICIANS AGREED THAT THE INSTRUMENT WAS PROPERLY REPORTING ACCUTNI RESULTS. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER CALLED BACK INTO HOTLINE ON (B)(6) 2009 AND STATED THE FOLLOWING: THE CUSTOMER SPOKE WITH THE FSE REGARDING THE TROPONIN ISSUES AND IT WAS DETERMINED THAT THE INSTRUMENT IS UNDER A VENT. THEY PINPOINTED THE RESULTS/MATCHING ISSUES ONLY OCCUR AT NIGHT WHEN THE LABORATORY GETS COOL. THE FSE REQUESTED THE LABORATORY FIND A DIFFERENT COUNTER FOR THE INSTRUMENT TO BE MOVED TO. THE CUSTOMER AGREED TO CONTACT BCI AGAIN TO COORDINATE A FSE VISIT TO MOVE THE INSTRUMENT. PER FSE, THE RESULTS APPEAR TO BE RELATED TO THE AMBIENT TEMPERATURE NEAR THE INSTRUMENT. THIS LOCATION OF THIS INSTRUMENT WAS MUCH COLDER THAN THE OTHER. THE INSTRUMENT WAS MOVED CLOSER TO THE OTHER. THE CASE TEMPERATURE OF THE TWO INSTRUMENTS IS MUCH CLOSER NOW. PERFORMANCE WAS VERIFIED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008, THROUGH (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. NEGATIVE TROPONIN RESULTS WERE OBTAINED FROM AN ALTERNATE TESTING METHODOLOGY. THE CUSTOMER DID NOT REPORT AFFECT TO PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1