BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172527 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01987
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    February 14, 2009
    Report Date
    February 15, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SVC WAS NOT DISPATCHED FOR THIS EVENT. THE FIELD SVC ENGINEER (FSE) DID NOT EVALUATE THE INSTRUMENT. A REVIEW OF THE DATA FOR A SYS CHECK RUN ON (B)(4) 2009 INDICATED THAT THE RESULTED WERE WITHIN SPECS. THE BCI CUSTOMER TECHNICAL SPECIALIST (CTS) DETERMINED PACK SHARING OCCURRED WHILE TROUBLESHOOTING WITH THE CUSTOMER VIA TELEPHONE AND UPON REVIEW OF THE INSTRUMENT'S REAGENT INVENTORIES. CUSTOMER ERROR IS THE ROOT CAUSE FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO POTENTIAL ERRONEOUS ACCU TNI (TROPONIN I) RESULTS GENERATED ON THE UNICEL DXI ACCESS IMMUNOASSAY SYS FOR UNSPECIFIED NUMBER OF PTS DUE TO PACK SHARING. THE CUSTOMER DID NOT PROVIDE ARCHIVE DATA FILES TO DETERMINE EXACT PT RESULTS. THE INITIAL ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LAB. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI