BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2060399 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-01008
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 16, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FOR COLLECTION DEVICES AND CENTRIFUGATION HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER SUPPLIED DATA, QC HAS BEEN PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SYSTEM CHECK HAS NOT BEEN SUPPLIED TO DATE. SERVICE HAS NOT BEEN DISPATCHED TO DATE FOR THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT 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 ACCUTNI RESULTS WITHIN RISK STRATIFICATION FOR ONE (1) PATIENT THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS OF THE SAMPLES ON THE SAME INSTRUMENT STILL GAVE RESULTS WITHIN RISK STRATIFICATION WHILE THE ANALYSIS OF THE SAMPLES ON A DIFFERENT METHOD GAVE "NORMAL" RESULTS. THE RESULTS, PROVIDED BY THE CUSTOMER. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR