BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2182844 · Received July 28, 2011

    Report

    Report Number
    2122870-2011-02554
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 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
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMS QC EVERY EIGHT HOURS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. DURING TROUBLESHOOTING WITH BEC CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS DISCOVERED THAT THERE WERE NO TBHCG REAGENT PACKS LOADED IN THE REAGENT STORAGE CAROUSEL. WHEN THIS OCCURS, THE INSTRUMENT DOES NOT DETECT THAT THERE IS NO REAGENT PACK PRESENT. PER CTS INSTRUCTIONS, THE CUSTOMER LOADED A NEW REAGENT PACK AND RAN QC.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING NO VALUE / IND FLAGS ON ALL LEVELS OF TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (T-HCG) ON THE ACCESS 2 IMMUNOASSAY ANALYZER. THE CUSTOMER STATED THAT THREE (3) PATIENT SAMPLES WERE ANALYZED FOR T-HCG DURING THE TIME FRAME OF EVENT. THE SAMPLES WERE LATER CONFIRMED TO BE NEGATIVE FOR T-HCG. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1