MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT DIFF ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6706366

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

While troubleshooting the coulter act diff analyzer the field service engineer (fse) found the wbc bath and the peristaltic pump tubing was defective.Erroneous patient results were not reported out of the laboratory and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 4/29/2015.The fse found that the wbc bath and the perstaltic pump tubing were defective.The fse replaced the wbc bath and the peristaltic pump tubing, which resolved the issue.The repairs were verified per established procedures.(b)(4).

• Brand Name: COULTER ACT DIFF ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-l23; miami, FL 33196 ; 3053802031
• MDR Report Key: 4798165
• MDR Text Key: 5880046
• Report Number: 1061932-2015-00867
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973634
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6706366
• Other Device ID Number: SOFTWARE VER 2.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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