BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2242327 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03413
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 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
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABORATORY USES LITHIUM HEPARIN GEL SEPARATOR TUBES FOR ACCUTNI SAMPLE COLLECTION. CENTRIFUGATION INFORMATION WAS NOT PROVIDED. THE CUSTOMER DID NOT PROVIDE SPECIFIC QUALITY CONTROL DATA. A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    WHEN CONTACTED BY BECKMAN COULTER INC. (BEC) VIA THE ACCUTNI MARKETING SURVEY PROGRAM (MSP), A CUSTOMER REPORTED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI RESULTS. THESE RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY ANALYZER AND WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DECLINED TO PROVIDE SPECIFIC DATA TO INCLUDE PATIENTS' DEMOGRAPHICS, SAMPLE DATA REPORT, AND EVENT DATES. THE CUSTOMER INDICATED THAT THE LABORATORY HAS A PROACTIVE PROCEDURE IMPLEMENTED TO VERIFY UNEXPECTED RESULTS PRIOR TO REPORTING RESULTS OUT OF THE LABORATORY. REPEAT ANALYSIS CRITERIA DETAILS WERE NOT PROVIDED. THE CUSTOMER DID NOT PROVIDE INFORMATION INDICATING AN INCREASE IN OCCURRENCE OR AN INSTRUMENT MALFUNCTION. PER THE CUSTOMER, THE DEVICE WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS UPON BEC CONTACT WITH THE CUSTOMER. THERE WERE NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT MADE IN CONNECTION WITH 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