BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2060328 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-00996
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PLASMA TUBE WITH A GEL SEPARATOR. CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. QC IS PERFORMED ONCE EVERY 24 HOURS, AND WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A ROUTINE SYSTEM CHECK PERFORMED ON (B)(4) 2011 PASSED WITHIN INSTRUMENT SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER HAS THEIR OWN BIO-MEDICAL ENGINEER (BME). BCI HAS MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION. HARDWARE VERIFICATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT, WITHIN THE RISK STRATIFICATION RANGE, GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED A LOWER RESULT THAT WAS STILL WITHIN THE RISK STRATIFICATION RANGE BUT OUTSIDE OF ASSAY PRECISION CLAIMS. THE PATIENT WAS TREATED WITH MEDICATION BUT THE SPECIFIC MEDICATION AND DOSAGE HAS NOT BEEN SUPPLIED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other