BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2230319 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03354
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT NEEDED TO BE REVISED TO REFLECT THAT THERE WERE NO DEATHS, SERIOUS INJURIES OR MODIFICATIONS TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. INVESTIGATION OF THIS EVENT IS ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILING LEVEL 1 TOTAL HUMAN CHORIONIC GONADOTROPIN (TBHCG) QUALITY CONTROL (QC) RESULTS WERE GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM IN ASSOCIATION WITH THE LOADING OF A NEW TBHCG REAGENT PACK ONTO THE INSTRUMENT. THE INSTRUMENT ASSAY LEVEL 1 QC RESULTS CONTINUED TO FAIL BY GREATER THAN 3 STANDARD DEVIATIONS UNTIL A NEW REAGENT PACK OF THE SAME LOT NUMBER WAS LOADED ON THE INSTRUMENT; AT SUCH TIME, THE INSTRUMENT ASSAY QC RESULTS AGAIN RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS. INSTRUMENT ASSAY LEVELS 2 AND 3 QC RESULTS PASSED WITHIN ESTABLISHED QC RANGES ON ALL ATTEMPTS. NO PATIENT RESULTS WERE ASSOCIATED WITH THIS EVENT AND HENCE THERE WERE DEATHS, SERIOUS INJURIES OR MODIFICATIONS TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    NO PATIENT RESULTS WERE ASSOCIATED WITH THIS EVENT AND HENCE THERE WERE NO DEATHS, SERIOUS INJURIES OR MODIFICATIONS TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL SSHCG REAGENT