BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2133164 · Received June 19, 2011

    Report

    Report Number
    2122870-2011-01813
    Event Type
    Malfunction
    Date Received
    June 19, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MXZ
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS DATA GENERATED. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT A HIGHER THAN EXPECTED RESULT FOR PROGESTERONE FOR 1 PATIENT SAMPLE ASSAYED WITH ACCESS PROGESTERONE REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULT WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY A NURSE. THE CUSTOMER IS UNSURE WHETHER OR NOT PATIENT CARE WAS IMPACTED DUE TO THE ERRONEOUS RESULT. THE CUSTOMER REPEATED THE PROGESTERONE ASSAY FOR THE PATIENT SAMPLE AND OBTAINED A SIMILAR RESULT. THE CUSTOMER THEN RECALIBRATED THE PROGESTERONE ASSAY WITH A NEW LOT OF REAGENT AND REPEATED THE PROGESTERONE ASSAY FOR THE PATIENT SAMPLE. THE RECALIBRATED ASSAY YIELDED A LOWER PROGESTERONE RESULT FOR THE PATIENT SAMPLE WHICH MORE CLOSELY REFLECTED THE CLINICAL PRESENTATION OF THE PATIENT. QUALITY CONTROL RESULTS BOTH BEFORE AND AFTER RECALIBRATION WITH THE NEW LOT OF REAGENT WERE ALL WITHIN ESTABLISHED RANGES. THE CUSTOMER SENT THE PATIENT SAMPLE TO BCI FOR ADDITIONAL ANALYSIS (RESULTS PENDING). A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS PROGESTERONE REAGENT