BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2152834 · Received July 7, 2011

    Report

    Report Number
    2122870-2011-02181
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN GEL BARRIER TUBE. SAMPLE WAS ALIQUOTED AND RE-SPUN PRIOR TO RE-TESTING. THE CUSTOMER HAS A REPEAT PROTOCOL FOR ANY FIRST TIME TROPONIN I RESULTS THAT ARE GREATER THAN 0.50 NG/ML. CUSTOMER STATED THEY HAVE HAD NO RECENT QC OR HARDWARE ISSUES. SYSTEM CHECK AND CALIBRATION DATA WERE NOT SUPPLIED BY THE CUSTOMER. SERVICE WAS NOT DISPATCHED AS CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    WHEN CONTACTED BY BECKMAN COULTER INC. (BEC) PER (B)(4) PROCEDURES, A CUSTOMER REPORTED THAT THEIR LABORATORY OBTAINED A NON-REPRODUCIBLE FALSE POSITIVE TROPONIN (ACCUTNI) RESULT FOR ONE (1) PATIENT, GENERATED BY AN ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS 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 FOR CLINICAL USE MMI BECKMAN COULTER INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1