BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2180338 · Received July 27, 2011

    Report

    Report Number
    2122870-2011-02591
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 30, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. PER THE COMPLAINT RECORD, THE CUSTOMER ALIQUOTS SAMPLES FOR TESTING AFTER CENTRIFUGING THE PRIMARY SAMPLE TUBE. QC WAS PERFORMED PRIOR TO THE EVENT OCCURRENCE AND PASSED WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SYSTEM CHECK DATA HAS NOT BEEN SUPPLIED TO DATE. A BEC SYSTEM SUPPORT SPECIALIST INFORMED THE CUSTOMER OF PRE-ANALYTICAL SAMPLE HANDLING CONCERNS WITH REGARD TO THE ACCUTNI ASSAY BEING SENSITIVE TO PRE-ANALYTICAL SAMPLE HANDLING ISSUES. SERVICE INFORMATION FOR THIS EVENT WAS NOT SUPPLIED TO DATE. ALTHOUGH SAMPLE HANDLING ISSUES WERE ADDRESSED WITH THE CUSTOMER, 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. (BEC) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR ONE (1) PATIENT SAMPLE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT PRODUCING LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY AS THE CUSTOMER DELAYED REPORTING ANY PATIENT RESULTS BY THIRTY (30) MINUTES UNTIL THE CORRECT RESULT WAS OBTAINED. 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 JJE BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1