BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2092674 · Received May 18, 2011

    Report

    Report Number
    2122870-2011-01424
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. CUSTOMER STATED THAT QC HAD BEEN RECOVERING WITHIN THEIR ESTABLISHED RANGES. DATA HAS NOT BEEN SUPPLIED TO DATE. WEEKLY MAINTENANCE WAS PERFORMED ON (B)(4) 2011 INCLUDING CLEANING PROBES AND A PASSING SYSTEM CHECK. WEEKLY MAINTENANCE INCLUDING SYSTEM CHECK HAD NOT BEEN PERFORMED UNTIL REQUESTED BY BCI CUSTOMER TECHNICAL SUPPORT ON (B)(4) 2011, FOLLOWED BY QC, RECOVERING WITHIN EXPECTED RANGE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT BECAUSE THE CUSTOMER DECLINED. USER ERROR DUE TO LACK OF MAINTENANCE IS ROOT CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) TO REPORT OBTAINING NUMEROUS ELEVATED TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR THREE (3) PATIENTS, GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LAB. REPEATED ANALYSIS OF SAMPLES RECOVERED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER STATED THERE WAS NO DEATH OR INJURY TO PATIENT REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1