MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number A30260

Device Problems Loose or Intermittent Connection (1371); High Test Results (2457); Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2014

Event Type  Injury  

Event Description

The customer contacted beckman coulter (bec) on (b)(6) 2014 to report obtaining non-reproducible troponin i (accutni+3) results involving the unicel dxi 600 access immunoassay system.The customer stated initial elevated accutni+3 results for five patients, generated by the unicel dxi 600, were reported outside of the laboratory and two of the patients underwent cardiac catheterization procedures due to the elevated results.The customer did not indicate which two of the five patients underwent the procedures.The physician questioned the results for one patient after negative findings from the cardiac catheterization.Upon repeat testing on an alternate unicel dxi 600 access immunoassay system, the results were lower and within reference range.The customer did not provide sample preparation information.Quality control was within the customer's established ranges prior to and after the events.The customer had passing accutni+3 calibration on (b)(4) 2014, using reagent lot 427865 and calibrator lot 334821.A beckman coulter field service engineer (fse) was at the facility on (b)(4) 2014 to address failing system check and calibration issues, and found the aspirate probe to be loosely connected.The fse tightened the connection to address the issue.The elevated results were generated before the fse was on site.Section a of this report refers to the information for patient number four (4).This is one of two reports.Mdr 2122870-2014-00799 reports the adverse event for the second patient.

Manufacturer Narrative

There is no evidence to suggest a malfunction as the sequence of events would suggest that the aspirate probe in question would not become loose due strictly to the motion of the internal connected subsystems.The customer had performed maintenance on the instrument on (b)(4) 2014 which included changing the aspirate probes although use error may have contributed to the event, a definitive cause cannot be determined.An fse was on site on (b)(4) 2014 and performed hardware verification.The instrument passed all tests without issue.Complete internal identifier for this report is (b)(4).Related mdrs: 2122870-2014-00798, 2122870-2014-00799.

Manufacturer Narrative

Corrected patient data table to include: reference range for the alternate instrument (s/n (b)(4)) was 0.00 ng/ml - 0.04 ng/ml.Date of birth of patient number one (1) was (b)(6).Age of patient five (5) was (b)(6).(b)(4).

• Brand Name: UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 4303668
• MDR Text Key: 5059405
• Report Number: 2122870-2014-00798
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A30260
• Other Device ID Number: SOFTWARE VERSION 5.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR