MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE

Catalog Number A25640

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

There were no reported patient results impacted by this event.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument.While on site the fse found an obstruction in one of the ports in the wash tower.He replaced the wash tower and o-rings.He also replaced the pipettor tip and performed all associated alignments.He rebuilt the precision pump with new seals and o-rings, cleaned the precision valve and verified the pipettor ultrasonics.He also confirmed the luminometer performance.After the repairs were complete, all verification testing passed within published instrument and assay performance specifications.In conclusion, the cause of this event is due to a hardware malfunction although no one part can be implicated.The replacement of several hardware components resolved the issue.System parameters recovered within specifications after replacement of these parts.(b)(4).

Event Description

The customer reported receiving an unacceptable (b)(4) survey result for human chorionic gonadotropin (access total bhcg (5th is) involving the access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system (serial number (b)(4)) for one specimen identified as (b)(6).The initial result was greater than (>) 1365 miu/ml and was reflexed using the customer's established diluted sample protocol and recovered at 1171miu/ml.The cap limits of acceptability for this sample are 1182.1miu/ml-2025.2 miu/ml.There was no report of questioned patients' results.Beckman coulter (bec) customer technical support (cts) suggested that the customer perform a dilution test to assess the performance of the instrument.The dilution test failed to meet specifications.Calibration, quality control (qc) and system check were performing within the assay's and instrument's specifications at the time of the event.A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument.

• Brand Name: UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela kilian ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5742784
• MDR Text Key: 47967612
• Report Number: 2122870-2016-00321
• Device Sequence Number: 0
• Product Code: DHA
• Reporter Country Code: US
• PMA/PMN Number: K060256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A25640
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2013
• 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