BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2032541 · Received March 29, 2011

    Report

    Report Number
    2122870-2011-00863
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION DATA WAS NOT SUPPLIED. QC DATA WAS NOT SUPPLIED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER TESTING. CPLS TESTING CONFIRMED THE PRESENCE A HETEROPHILE INTERFERENT WHICH LIKELY RELATES TO ALKALINE PHOSPHATASE, WHICH IS OBSERVED AS THE ROOT CAUSE OF THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE OF (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) IN REGARDS TO OBTAINING ELEVATED TROPONIN (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF, FOR ONE (1) PATIENT, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THERE HAS BEEN NO REPORT OF PATIENT INJURY, DEATH, OR CHANGE TO TREATMENT RECEIVED TO BCI TO DATE.

    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 92 YR