MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT 5DIFF CAP PIERCE (CP); COUNTER, DIFFERENTIAL CELL

Catalog Number 6605641

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

While troubleshooting an unrelated issue, a field service engineer (fse) discovered that the aspiration probe was bent on a coulter act 5diff cap pierce (cp).Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

The fse replaced the sample probe and checked probe alignment to resolve the issue.The repair was verified per established service procedures.(b)(4).

• Brand Name: COULTER ACT 5DIFF CAP PIERCE (CP)
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-l23; miami, FL 33196 ; 3053802031
• MDR Report Key: 4731820
• MDR Text Key: 5747739
• Report Number: 1061932-2015-00696
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042173
• 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: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• 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