MAUDE Adverse Event Report: BECKMAN COULTER ACCESS® 2 IMMUNOASSAY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number 81600N

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

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

Event Date 03/15/2014

Event Type  malfunction  

Event Description

The customer reported non-reproducible troponin i (access® accutni+3) results, for five patients, involving the access® 2 immunoassay system.This report is two of two referencing the patient on the event date noted.The customer stated the results were released out of the laboratory and was uncertain if patient care was impacted.There has been no report of patient injury or change in patient treatment associated with this event.The customer stated all troponin samples are reanalyzed in duplicate when results do not correlate for multiple patient samples, per laboratory protocol.The customer then reanalyzed the samples, in duplicate and on the same instrument, and obtained varied results.The customer noted issues with quality control (qc) level 1 and system check failed the unwashed portion at the time of the event.The patients' samples were collected in 5 or 7 ml lithium heparin tubes and centrifuged at 3,900 rpm (rotations per minute) for five minutes.The original and retest samples were analyzed in primary tubes.Beckman coulter customer technical support (cts) assisted the customer in disassembling, cleaning and reassembling the wash valve.The customer primed the instrument four times and repeated system check, but it continued to fail the unwashed portion.Beckman coulter cts advised the customer to reanalyze all patient samples back to the last acceptable system check.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

The field service engineer (fse) replaced the pipettor probe tip, verified ultrasonics, tightened the z belt for the pipettor gantry, replaced the precision pump valve seal and rotor shaft and rebuilt the precision pump assembly.The fse performed three successful level sense tests and an unwashed portion of the system check, which failed.The fse noted the pipettor not completing the downward motion before reaching the fluid and did not generate a level sense error and replaced the pipettor gantry assembly.The fse performed a successful quality control (qc), system check, and precision test.Results met published performance specifications.Service activity performed was verified to meet the specified requirements per established procedures.The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.In conclusion, the likely cause of the event is attributed to the pipettor gantry which was not allowing samples or fluids to be properly sensed.Beckman coulter continues to track and trend any incident related to this issue.This medwatch report is related to mdr 2122870-2014-00253.

• Brand Name: ACCESS® 2 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: 3746191
• MDR Text Key: 4422200
• Report Number: 2122870-2014-00254
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922823/A007
• 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: 03/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81600N
• Other Device ID Number: SOFTWARE VERSION 3.3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2009
• 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