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

Catalog Number 81600N

Device Problem High Test Results (2457)

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

Event Date 05/01/2014

Event Type  malfunction  

Event Description

The customer reported falsely elevated initial prostate-specific antigen (psa) results, for two patients, involving the access 2 immunoassay system.This report is three of three referencing the patient on the event date noted.The customer stated the falsely elevated result was released out of the laboratory and questioned by the physician as the value did not correlate with the patient's clinical condition.There was no report of patient injury or change in patient treatment associated with this event.Subsequent testing of the patient's sample, on the same instrument, produced lower results within the normal reference range.The laboratory determines psa results of less than (<) 4 ng/ml to be normal.The patients' samples were collected in 16x100 mm serum separation tubes and analyzed on the same day.No sample integrity issues were noted.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

The field service engineer (fse) replaced the main pipettor probe and the upper and lower precision pump seals.The fse noted high sensitivity system check was not within specifications.On (b)(4) 2014, the fse replaced the mixer rollers and pinch rollers.The fse also replaced the substrate probe, vacuum bottle, and the peristaltic pump tubing (the substrate probe and peristaltic pump tubing were replaced due to kink).The fse verified alignments and the wash carousel bearings were within specifications.The fse completed system check and high sensitivity system check; both passed within specifications.The fse verified quality control (qc) was within the laboratory's established limits and completed a successful 15-replicate precision test.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, system hardware is the likely cause of the event as repairs resolved the reported issue.However, a specific hardware component was not identified as the singular cause of the event.All related medwatch reports associated with this incident: 2122870-2014-00398, 2122870-2014-00399, 2122870-2014-00403.

• 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: 3825817
• MDR Text Key: 18931814
• Report Number: 2122870-2014-00403
• Device Sequence Number: 1
• Product Code: LTJ
• 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: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81600N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2010
• 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