MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605500

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

The customer reported white blood cell (wbc) and hemoglobin test results were not generated during the startup process when using the coulter act diff 2 analyzer.Beckman coulter customer technical support (cts) assisted the customer is performing troubleshooting, however the platelet parameter failed and wbc results were not generated during repeats of the startup process.The customer then identified the wbc bath appeared to be overflowing.A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the analyzer.The fse did not confirm the wbc both overflow, and identified a bent aspiration needle.The customer was wearing personal protective equipment of gloves, goggles, and lab coat.There were no exposure of mucous membranes or cuts to biohazardous material.There were no erroneous test results associated with this event.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the analyzer and could not confirm nor replicate the issues reported by the customer.He did find that the aspiration needle (probe) was slightly bent and replaced it.Fse then performed verification of instrument to meet the specified requirements per established procedures.(b)(4).

• Brand Name: COULTER ACT DIFF 2 ANALYZER
• 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 avenue; miami FL 33196
• Manufacturer Contact: dung nguyen ; 250 s kraemer blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 4287044
• MDR Text Key: 5297180
• Report Number: 1061932-2014-02910
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990352
• 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: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605500
• Other Device ID Number: SOFTWARE VERSION: 2.01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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