BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2231975 · Received September 1, 2011

    Report

    Report Number
    2122870-2011-03128
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCUTNI SAMPLES WERE COLLECTED IN 13X100MM SERUM TUBES WITH A GEL SEPARATOR AND ARE CENTRIFUGED FOR 10 MINUTES AT 3200 RPM. THE INTERNATIONAL BEC SPECIALIST NOTED THAT THE TIME FROM DRAW TO ANALYSIS WAS ONLY 35 MINUTES. THIS AMOUNT OF TIME MAY NOT HAVE ALLOWED FOR ADEQUATE CLOTTING PRIOR TO CENTRIFUGATION. THE INTERNATIONAL BEC SPECIALIST REVIEWED PROPER SAMPLE HANDLING AND PRE-ANALYTICAL FACTORS WITH THE CUSTOMER. PER THE CUSTOMER COMPLAINT RECORD, ACCUTNI QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. ACCUTNI QC IS PERFORMED EVERY EIGHT HOURS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE AT THIS TIME. ALTHOUGH PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THIS EVENT, A DEFINITIVE ROOT CAUSE 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 AND ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF FOR ONE (1) PATIENT'S SAMPLE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. UPON REPEAT, SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. 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 UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1