BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2356054 · Received December 1, 2011

    Report

    Report Number
    2122870-2011-05723
    Event Type
    Injury
    Date Received
    December 1, 2011
    Date of Event
    February 25, 2010
    Report Date
    March 4, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MXZ
    PMA / PMN Number
    K922826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BEC) TO REPORT AN ERRONEOUS PROGESTERONE PT SAMPLE RESULT GENERATED ON THEIR ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS PT SAMPLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. BASED ON THE ERRONEOUS PT SAMPLE RESULT, THE PHYSICIAN ADMINISTERED PROGESTERONE TO THE PT. WHEN THE PHYSICIAN ORDERED A SUBSEQUENT PROGESTERONE TEST, THE RESULT WAS UNEXPECTEDLY LOW. THE PHYSICIAN SUSPECTED A DISCREPANCY BETWEEN THE CLINICAL PRESENTATION OF THE PT AND THE PROGESTERONE RESULT. SYSTEM CHECK AND QUALITY CONTROL DATA HAVE NOT BEEN PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS IMMUNOASSAY SYSTEM MXZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ACCESS PROGESTERONE REAGENT