BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2199935 · Received August 10, 2011

    Report

    Report Number
    2122870-2011-02688
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUPPLY SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION. THE SAMPLE WAS ORIGINALLY ASPIRATED FROM THE PRIMARY COLLECTION TUBE FOR ANALYSIS. PRIOR TO REPEAT TESTING, THE SAMPLE WAS ALIQUOTED AND RE-CENTRIFUGED. FOUR LEVELS OF QC ARE PERFORMED EVERY 8 HOURS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE EVENT. SYSTEM CHECKS ARE PERFORMED WEEKLY AND ARE MEETING SPECIFICATIONS WITHOUT ANY ISSUES. ON (B)(6), 2011, A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT. THE FSE CLEANED THE WASH AND PRECISION PUMPS, AND REPLACED THE SEALS. THE FSE VERIFIED AND MADE THE NECESSARY ADJUSTMENTS TO ALIGNMENTS. ALL VERIFICATION TESTING MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING A TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT. THE RESULT WAS GENERATED BY AN ACCESS 2 IMMUNOASSAY ANALYZER, USED IN CONJUNCTION WITH ACCESS ACCUTNI REAGENT (LOT 110411) AND ACCESS ACCUTNI CALIBRATORS (LOT 018863). THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB. REPEAT ANALYSIS OF THE PATIENT'S SAMPLE ON THE SAME INSTRUMENT PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN MADE IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1