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

Catalog Number 81600N

Device Problem Imprecision (1307)

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

Event Date 01/08/2014

Event Type  malfunction  

Event Description

The customer reported troponin i (access accutni) quality control (qc) failures involving the access 2 immunoassay system.Upon repeat, qc was within range.The laboratorys qc range is 0.13 - 0.41 ng/ml.Qc was out of range at 0.17 ng/ml.The customer indicated system check was within specification on the day of the event.The customer then performed quality control on the alternate access 2 system and quality control was within range.The customer stated quality control (qc) is always performed prior to analyzing patient samples when using this instrument.Patient samples are not analyzed if qc fails.There was no report of erroneous patient results.There was no report of impact to patient care associated with this event.A beckman coulter field service engineer (fse) assessed the instrument at the facility.

Manufacturer Narrative

The field service engineer (fse) replaced the peristaltic pump for the aspirate probes and resolved the issue.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 incident is attributed to the peristaltic tubing for the aspirate probes.Beckman coulter continues to track and trend any incident related to this issue.Beckman coulter internal identifier for this report is (b)(4).

• 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: 3598546
• MDR Text Key: 16223718
• Report Number: 2122870-2014-00069
• 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: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• 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 2.8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2010
• 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