BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2256753 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02990
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO INVESTIGATE THE EVENT AS REAGENT PACK SHARING WAS PROVEN. THE FIELD SERVICE ENGINEER DID NOT EVALUATE THE INSTRUMENT. A BCI CUSTOMER TECHNICAL SPECIALIST CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER OVER THE PHONE AND DISCOVERED THAT THE CUSTOMER IS SHARING REAGENT PACKS BETWEEN TWO INSTRUMENTS. CUSTOMER ERROR IS THE ROOT CAUSE FOR THIS EVENT. THIS IS 5 OF 5 SEPARATE MDR REPORTS RELATED TO 5 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: 2122870-2011-02963, 02987, 02988, 02989 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 THROUGH (B)(6) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRATIC ACCUTNI (TROPONIN I) RESULT GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE INITIAL RESULT WAS REPORTED OUTSIDE THE LAB. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI