BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2080834 · Received May 6, 2011

    Report

    Report Number
    2122870-2011-01260
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 6, 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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. THREE LEVELS OF CONTROLS WERE EXTREMELY HIGH, >128, ON DAY OF EVENT. PROGESTERONE IS A COMPETITIVE ASSAY. RLUS AND ANALYTE CONCENTRATION ARE INVERSELY RELATED. WITHOUT A REAGENT PACK PRESENT, ALL SAMPLES ON A COMPETITIVE ASSAY WILL RECOVER EXTREMELY HIGH CONCENTRATIONS AND VERY LOW RLU COUNTS. THE CUSTOMER DID NOT FOLLOW THE OUTLINED PROCEDURE FOR LOADING A NEW REAGENT PACK ON THE INSTRUMENT. SERVICE WAS NOT DISPATCHED BECAUSE CUSTOMER HAD RESOLVED MIS-LOADED PACK ISSUE ROOT CAUSE IS ASSOCIATED WITH USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A REAGENT PACK MIS-LOAD THAT LED TO AN ERRONEOUS PROGESTERONE RESULT FOR ONE (1) PATIENT, GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1