BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1915840 · Received December 6, 2010

    Report

    Report Number
    2122870-2010-00849
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS A CLEAR FULL SERUM ALIQUOT DRAW. QC WAS PERFORMING WITHIN QC SPECIFICATIONS. SERVICE WAS NOT DISPATCHED. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT. CHANGE: FROM: DATE OF (B)(6) 2010, TO: (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS A CLEAR FULL SERUM ALIQUOT DRAW. QC WAS PERFORMING WITHIN QC SPECIFICATIONS. SERVICE WAS NOT DISPATCHED. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED ACCUTNL ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF GENERATED BY THE UNICEL DXI 800 IMMUNOASSAY ANALYZER. THE RESULT WAS SUBMITTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED AND NEGATIVE RESULT WAS OBTAINED. PATIENT RESULTS ARE PROVIDED. THE CUSTOMER DID NOT REPORT ANY ISSUES OR CONCERNS IN REGARDS TO PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED ACCUTNI ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF GENERATED BY THE UNICEL DXI 800 IMMUNOASSAY ANALYZER. THE RESULT WAS SUBMITTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED AND NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER DID NOT REPORT ANY ISSUES OR CONCERNS IN REGARDS TO PATIENT OR USER 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. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1