BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2210811 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02888
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RAN A SYSTEM CHECK AND THE RESULTS PASSED ALL SPECIFICATIONS. THE CUSTOMER CONFIRMED THAT THERE ARE TWO ACCESS 2 SYSTEMS IN THE LAB, BUT THEY ARE NETWORKED TOGETHER TO PREVENT PACK SHARING. SERVICE WAS DISPATCHED FOR THIS EVENT AND ON-SITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) STATED THAT THE TWO ACCESS 2 INSTRUMENTS ARE NOT NETWORKED TOGETHER VIA THE SAME PC TO PREVENT PACK SHARING, BUT NETWORKED ON THE HOSPITAL'S NETWORK VIA THE LIS. THE FSE STATED THAT HE REVIEWED THE REAGENT INVENTORY PRINTOUTS FOR BOTH ACCESS 2 SYSTEMS, AND CONCLUDED THE CUSTOMER WAS SHARING REAGENT PACKS BETWEEN THE TWO SYSTEMS. WHEN THIS OCCURS, THE INSTRUMENT DOES NOT DETECT THAT THE PACK'S TEST COUNT IS INCORRECT. THE FSE LOADED A NEW REAGENT PACK ON THE INSTRUMENT AND RAN QC. USE ERROR OF REAGENT PACK SHARING WAS THE ROOT CAUSE OF THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING TOTAL BETA HUMAN CHORIONIC GONADOTROPINS (TBSCG) QC RESULTS OF 0.00 NG/ML OBTAINED FROM ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER LOADED A NEW TBHCG REAGENT PACK AND FAILED CALIBRATION. THE CUSTOMER RAN QC IMMEDIATELY AFTER THE FAILED CALIBRATION AND THE QC RESULTS CAME BACK WITHIN THE ESTABLISHED RANGES ON THE PREVIOUS CALIBRATION CURVE. THE CUSTOMER IS NOT QUESTIONING ANY PATIENT RESULTS. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1