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

Catalog Number A71460

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient results impacted by this event.The beckman coulter (bec) field service engineer (fse) performed a failing high sensitivity system check.The fse noted a malfunctioning mixer belt and replaced the mixer belt.This malfunction has the potential to cause the analyzer to generate erroneous patient results.However, there is no indication that this potential was realized in this instance.The non-reproducible access accutni+3 results reported by the customer were obtained one week before this malfunction occurred.The fse proactively performed a preventative maintenance.The fse verified repairs by performing a passing system check, high sensitivity system check and access accutni+3 precision run.

Event Description

On (b)(6) 2015, the customer reported obtaining non-reproducible troponin i (access accutni+3) results, on the laboratory's unicel dxi 600 access immunoassay system (serial number 900586).The non-reproducible access accutni+3 results were obtained on (b)(6) 2015.All system parameters, including access accutni+3 quality control (qc), access accutni+3 calibration and system check were within assay and instrument specifications.A beckman coulter (bec) field service engineer (fse) was dispatched to assess instrument performance.

• Brand Name: UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• 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: jeffery koll ; 1000lake hazeltine drive; chaska, MN 55318 ; 9523681361
• MDR Report Key: 5369949
• MDR Text Key: 36278432
• Report Number: 2122870-2016-00038
• Device Sequence Number: 0
• Product Code: MMI
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A71460
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2012
• 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