BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2123372 · Received June 14, 2011

    Report

    Report Number
    2122870-2011-01877
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL SAMPLE WAS A SHORT DRAW COLLECTED IN A SERUM TUBE. THE SPECIMEN WAS HEMOLYZED. NO SPECIFIC EVENT QC DATA WAS SUPPLIED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT DUE TO THE EVENT OCCURRING OVER 60 DAYS AGO. A ROOT CAUSE FOR THESE EVENTS WAS NOT DETERMINED.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) CONTACTED THIS CUSTOMER VIA THE TROPONIN (ACCUTNI) MARKETING SURVEY PROGRAM (MSP) CUSTOMER CONTACT PROGRAM. THE CUSTOMER INDICATED SOME OCCURRENCES OF NON-REPRODUCIBLE "HIGH" ACCUTNI PATIENT RESULTS. A SUBSEQUENT SAMPLE WAS DRAWN AND RESULTED "LOW". REPEAT OF THE INITIAL SAMPLE RECOVERED "LOW". ACTUAL PATIENT RESULTS WERE NOT SUPPLIED. THE CUSTOMER DID NOT REPORT EFFECT TO THE 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 JJE BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1