MAUDE Adverse Event Report: BECKMAN COULTER INC.UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMDISCRETE PHOTOMETRIC CHEMISTRY ANALYZER

Catalog Number 973100

Event Date 03/04/2004

Event Type  Other   Patient Outcome  Other

Event Description

A customer called beckman coulter regaridng 3 erroneously elevated accu tni results from 3 different pts that were generated by a unicel dxi instrument. Pt a had an accu tni result of 0. 711 ng/ml. Pt b had an accu tni result of 0. 792 ng/ml. Pt c had an accu tni result of 0. 965 ng/ml. The elevated result from pt a was reported out of the lab. The lab retested the pt (a) sample (on a different chemistry analyzer) and the accu tni result was 0. 002 ng/ml. The lab released a corrected lab report for pt a. The elevated accu tni result from pt b anc c were not reported out of the lab. The lab retested the pt (b) sample (on a different chemistry analyzer) and the accu tni result was 0. 176 ng/ml. The lab retested the pt (c) sample (on a different chemistry analyzer) and the accu tni result was 0. 034 ng/ml. The customer did not provide additional info regarding pt b and c. The customer did not receive any report of pt injury requiring medical intervention or change to pt treatment attributed to or connected with this event.

Manufacturer Narrative

(1) the customer indicated that the qc was within the expected range before and after the event occurred. (2) the customer was unable to provide any additional info regarding pt b and pt c. (3) service summary (post-event): a) the field service engineer (fse) performed a probe maintenance procedure and inspected/cleaned the wash wheel. I) the fse discovered a dirty wash wheel. Ii) the dirty wash wheel may have contributed to the erroneous results. B) the fse conducted a performance test on the instrument after the pm and the instrument passed within specifications. C) the fse stated that the instrument was performing within specifications after service. No other issues were discovered during this service call. 4) beckman coulter is unable to conclusively assign a root cause for this event. A malfunction will be assumed for the purpose of this report.

• Brand Name: UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
• Type of Device: DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
• Baseline Brand Name: UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
• Baseline Generic Name: DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE
• Baseline Catalogue Number: 973100
• Baseline Device Family: NA
• Baseline Device 510(K) Number: K023764
• Is Baseline PMA Number Provided?: No
• Baseline Preamendment?: No
• Transitional?: No
• 510(K) Exempt?: No
• Shelf Life(Months): NA
• Date First Marketed: 06/17/2003
• Manufacturer (Section F): BECKMAN COULTER INC.; 1000 lake hazeltine dr.; chaska MN 55318
• Manufacturer (Section D): BECKMAN COULTER INC.; 1000 lake hazeltine dr.; chaska MN 55318
• Manufacturer Contact: anne saber, director ; 11800 sw 147th avenue; mailstop: 32-c06; miami , FL 33116-9015; (305) 380 -2618
• Device Event Key: 535490
• MDR Report Key: 546082
• Event Key: 518677
• Report Number: 2122870-2004-00023
• Device Sequence Number: 1
• Product Code: JJE
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/06/2004

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/06/2004
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 973100
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 07/01/2003
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Invalid Data

Patient TREATMENT DATA

Date Received: 04/06/2004 Patient Sequence Number: 1

#	Treatment	Treatment Date
NA