MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 973100

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/02/2014

Event Type  malfunction  

Event Description

The customer reported inconsistent beta human chorionic gonadotropin results for two patient samples on two dates on a unicel dxi 800 access immunoassay system.The patient samples were tested for both total-beta human chorionic gonadotropin (tbhcg) and diluted total-beta human chorionic gonadotropin (dil-hcg.) the customer stated that there may have been two additional occurrences of inconsistent tbhcg and dil-hcg results, but did not provide any further details.This mdr reports the results generated on (b)(6) 2014.On (b)(6) 2014, the tbhcg and dil-hcg results for one patient were greater than and less than the reference range, respectively, on an initial analysis.The sample was reanalyzed on the same instrument and on an access 2 immunoassay system in the laboratory; dil-hcg results within the reference range were generated upon rerun.There was no change to patient treatment in association with this event.

Manufacturer Narrative

Beckman coulter (bec) customer technical support (cts) advised the customer to perform a test to assess the dilution performance of the instrument, which failed.A bec field service engineer (fse) was dispatched to evaluate the instrument.The fse replaced the pipettor tip, tubing, aspirate probes, red and white fitting, as well as aligned the reagent pipettor.Associated mdr: 2122870-2014-00436.

• Brand Name: UNICEL DXI 800 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 CHASKA; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 3900880
• MDR Text Key: 4540622
• Report Number: 2122870-2014-00437
• Device Sequence Number: 1
• Product Code: DHA
• 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
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 973100
• Other Device ID Number: SW VERSION 4.6.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2008
• 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 Age: 38 YR