BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2132998 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01929
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED. THE CUSTOMER INDICATED THAT ALL SAMPLES WERE FILTERED. PER THE CUSTOMER, THE CUSTOMER PERFORMED A DIAGNOSTIC SYSTEM CHECK ON (B)(4) 2011, AT THE ADVICE OF THE BCI HOTLINE. ALL PORTIONS PASSED WITHIN PUBLISHED SPECIFICATIONS. PER THE CUSTOMER'S QC CHARTS, THREE LEVELS OF QC ARE RUN EVERY EIGHT HOURS. ALSO, AN ULTRA LOW QC IS RUN ONCE EVERY 24 HOURS. ALL QC WAS WITHIN +/- 2 STANDARD DEVIATION (SD) OF ESTABLISHED MEAN PRIOR TO AND ON THE DAY OR EVENT. SERVICE WAS OFFERED BUT WAS DECLINED BY THE CUSTOMER AS THE CUSTOMER INDICATED THAT THERE IS A BIOMEDICAL STAFF FOR INSTRUMENT MAINTENANCE. NO ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT WITH THE DATA SUPPLIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING DISCREPANT RESULTS BETWEEN TWO (2) ACCESS 2 IMMUNOASSAY SYSTEMS FOR TROPONIN (ACCUTNI) ON ONE (1) PATIENT'S SAMPLE. ALL RESULTS WERE WITHIN THE RISK STRATIFICATION RANGE, WHICH ARE SHOWN. 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 JJE BECKMAN COULTER INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1