BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2240455 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03379
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 12, 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
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER SUPPLIED QC DATA, PRIOR TO THE EVENT ACCUTNI QC FAILED OUT OF RANGE LOW FROM 3 TO 5 STANDARD DEVIATION (SD) WHEN RUN ON THE REAGENT PACK - SERIAL #(B)(4). WHEN THE REAGENT PACK WAS REPLACED WITH A NEW ONE (SERIAL #(B)(4)) ACCUTNI QC PASSED WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE CUSTOMER INDICATED THAT THE ACCUTNI REAGENT PACK - SERIAL #(B)(4) IS BEING SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER INVESTIGATION. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING LOWER THAN EXPECTED TROPONIN (ACCUTNI) PATIENT (SIX PATIENT RESULTS) AND QC RESULTS, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON A NEW REAGENT PACK PRODUCED HIGHER RESULTS WITHIN THE SAME CLINICAL CATEGORY BUT OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM OF 8% FOR ALL SIX PATIENTS INVOLVED. IT IS UNKNOWN IF THE CUSTOMER RECEIVED 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 JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1