BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1863943 · Received October 11, 2010

    Report

    Report Number
    2122870-2010-00599
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECALIBRATION OF THE ASSAY ON A NEW BNP REAGENT PACK PRODUCED A PASSING CALIBRATION CURVE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE LIKELY ROOT CAUSE WAS DISCOVERED DURING TROUBLESHOOTING. REAGENT PACK SHARING IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING NO VALUE, INDETERMINATE (IND) FLAGGED RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ON SEVERAL PATIENTS' SAMPLES AND FAILED CALIBRATION FOR THE BRAIN NATRIURETIC PEPTIDE (BNP) ASSAY. WHILE TROUBLESHOOTING WITH ACCESS HOTLINE, A BNP REAGENT PACK WAS FOUND TO HAVE BEEN SHARED BETWEEN THE CUSTOMER'S DXI AND ACCESS SYSTEMS. 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 JJE BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1