BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1992256 · Received February 15, 2011

    Report

    Report Number
    2122870-2011-00402
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, A PROACTIVE PROCEDURE HAS BEEN IMPLEMENTED TO VERIFY UNEXPECTED RESULTS PRIOR TO REPORTING RESULTS OUTSIDE THE LAB THEREBY PREVENTING POTENTIAL RISK TO PATIENT SAFETY. THE CUSTOMER PROCEDURE IS TO REPEAT ANY INITIAL ACCUTNI VALUE THAT IS GREATER THAN 0.50NG/ML. THE CUSTOMER EMPHASIZED THAT THEY RE-SPIN THE SPECIMEN(S) PRIOR TO RETESTING. SERVICE WAS OFFERED AT THE TIME OF INITIAL CONTACT, BUT THE CUSTOMER DECLINED AS THERE WERE NO INSTRUMENT MALFUNCTIONS REPORTED FOR THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. REPEAT ANALYSIS OF EACH SPECIMEN GAVE NORMAL RESULTS. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. NO SPECIFIC PATIENT RESULTS WERE PROVIDED BY THE CUSTOMER. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR ANY CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS® 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1