MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTLAL CELL

Catalog Number 629029

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Not Applicable (3189)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument on (b)(6) 2015.The fse replaced the white blood cell, wbc, bath which addressed the contaminated hgb chamber.The repairs were verified per established service procedures.(b)(4).

Event Description

While the field service engineer (fse) was troubleshooting an unrelated event, the fse discovered build-up in the hemoglobin, hgb chamber from a unicel dxh 800 coulter cellular analysis system.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

Date of manufacturing has been revised to reflect correct date.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTLAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; kendall FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue; 32-s08; kendall, FL 33196 ; 3053802031
• MDR Report Key: 5189041
• MDR Text Key: 29878484
• Report Number: 1061932-2015-01589
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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