BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1943218 · Received December 30, 2010

    Report

    Report Number
    2122870-2010-00990
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 2, 2010
    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
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. THE CUSTOMER DILUTED THE SAMPLE WITH SEVERAL DILUENTS. IT IS UNKNOWN IF THE CUSTOMER WAS USING THE DILUENT AS RECOMMENDED IN THE IFU (INSTRUCTION FOR USE). THE CUSTOMER SENT THE SAMPLES TO BCI FOR FURTHER TESTING, BUT THE SAMPLE HAS NOT BEEN RECEIVED TO DATE. A ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO AN ELEVATED TROPONIN (ACCUTNI) RESULT ABOVE AMI CUTOFF GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE. THE RESULT WAS REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING BY AN ALTERNATE METHOD PRODUCED SIMILAR RESULTS. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1