BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2111647 · Received June 2, 2011

    Report

    Report Number
    2122870-2011-01652
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLASSIFICATION PRODUCT CODE OF THE SUSPECT MEDICAL DEVICE INVOLVED WAS INCORRECTLY IDENTIFIED AS CGN IN THE ORIGINAL 3500A. THE CORRECT CLASSIFICATION PRODUCT CODE IS JJE.

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER SUSPECTED POSSIBLE SAMPLE INTERFERENCE AS A CONTRIBUTING CAUSE OF THIS EVENT AND WAS TO SUBMIT A SAMPLE TO BECKMAN COULTER INC. FOR INTERFERENCE TESTING. NO SAMPLE HAS BEEN RECEIVED TO DATE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A HIGHER THAN EXPECTED HUMAN CHORIONIC GONADOTROPIN (BHCG) WAS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT SERUM SAMPLE. THE PATIENT HAS A HISTORY OF ELEVATED BHCG TESTS RESULTS. THE DETAILS, DATES AND PATIENT IMPACT SURROUNDING THESE PREVIOUS EVENTS ARE UNKNOWN. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT UNDERWENT A PROCEDURE TO ASSESS FOR PREGNANCY BASED UPON THE ERRONEOUSLY ELEVATED BHCG RESULT. A URINE SAMPLE TEST ON 05/09/2011, ON THE SAME INSTRUMENT, GENERATED A LOWER BHCG VALUE THAT WAS CONSIDERED VALID. QUALITY CONTROL RESULTS WERE PERFORMING WITHIN CUSTOMER ESTABLISHED RANGES AT THE TIME OF THE EVENT. NO SYSTEM CHECK DATA WAS PROVIDED BY THE CUSTOMER.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention ACCESS TOTAL SSHCG