BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2420929 · Received January 19, 2012

    Report

    Report Number
    2122870-2012-00038
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 22, 2011
    Report Date
    December 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. CUSTOMER SUPPORT ASSESSED THE EVENT VIA TELEPHONE COMMUNICATIONS. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. ASSOCIATED MDRS: 2122870-2012-00038, 2122870-2012-00121.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING FAILING T-UPTAKE QUALITY CONTROL (QC) RESULTS AND PREMATURELY EMPTY FOLLICLE STIMULATING HORMONE (FSH) REAGENT PACKS. THIS REPORT ADDRESSES THE FAILING T-UPTAKE QC RESULTS GENERATED FROM AN ACCESS 2 IMMUNOASSAY SYSTEM AFTER THE CUSTOMER PERFORMED A PASSING T UPTAKE CALIBRATION WITH LOWER THAN EXPECTED RELATIVE LIGHT UNITS (RLUS) FOR THE SOLE, S0 CALIBRATOR USED TO CALIBRATE THE ASSAY. SUBSEQUENT RECALIBRATION OF THE T-UPTAKE ASSAY ON A NEW REAGENT PACK PRODUCED S0 CALIBRATION RESULTS GREATER THAN ONE HUNDRED FORTY THOUSAND RLUS. THE CUSTOMER WAS THEN ABLE TO OBTAIN QUALITY CONTROL RESULTS WITHIN THEIR ESTABLISHED LIMITS. BECKMAN COULTER INC. CUSTOMER TECHNICAL SUPPORT ADVISED THE CUSTOMER TO REVIEW PATIENT DATA TO ENSURE NO ERRONEOUS RESULTS HAVE BEEN OBTAINED AS PART OF THIS EVENT. THE CUSTOMER INDICATED THAT 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. REAGENT SHARE PACKING WAS SUSPECTED BUT NOT CONFIRMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS T-UPTAKE REAGENT