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); Calibration Problem (2890); Device Operates Differently Than Expected (2913)

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

Event Date 03/21/2014

Event Type  malfunction  

Event Description

The customer reported failed calibrations and ind (indeterminate) flagged access® accutni+3 results, for five patients, on separate event dates, involving the access® 2 immunoassay system.The ind results (non-numerical) were not released from the laboratory.The customer reanalyzed the patients' samples on the alternate access® 2 instrument and obtained lower results.There was no patient injury or change in patient treatment associated with this event.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

The field service engineer (fse) adjusted the mixer speed from 2,450 rpm to 2,500 rpm (rotations per minute).The fse noted the ultrasonic voltage was at 228 volts and adjusted it to 197 volts (incorrect voltage may cause insufficient mixing of the magnetic particles).The fse performed a passing system check, high sensitivity system check, and 15-replicate precision test.Service activity performed was verified to meet the specified requirements per established procedures.Results met published performance specifications.The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.In conclusion, system hardware, associated with the transducer voltage, is the likely cause of the event.Beckman coulter continues to track and trend any incident related to this issue.All related medwatch reports associated with this incident: 2122870-2014-00274; 2122870-2014-00275; 2122870-2014-00276; 2122870-2014-00277.

• 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: 3760225
• MDR Text Key: 15805337
• Report Number: 2122870-2014-00275
• 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: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• 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: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2009
• 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