BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1844084 · Received September 24, 2010

    Report

    Report Number
    2122870-2010-00562
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS PLASMA. QC PERFORMED PRIOR TO AND AFTER THE EVENT WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A SYSTEM CHECK PERFORMED JUST BEFORE THE EVENT WAS WITHIN SPECIFICATIONS. THERE WERE NO ERRORS POSTED TO THE EVENT LOG. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED THE SUBSTRATE PROBE AND VERIFIED ALIGNMENTS. THE FSE RAN REPLICATES OF LEVEL 2 QC ON TWO NEW REAGENT PACKS; RESULTS WERE WITHIN PRECISION CLAIMS. THE FSE PERFORMED A DIAGNOSTIC TEST WHICH MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A FALSELY LOW TROPONIN (ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION RANGE, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. REPEAT TESTING ON THIS AND ON A DIFFERENT INSTRUMENT PRODUCED RESULTS ABOVE THE AMI CUTOFF. THE LOW RESULT WAS NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH 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. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1