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

Catalog Number 629029

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

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

Event Date 07/16/2014

Event Type  malfunction  

Event Description

The customer reported r (review result) flagging occurred on a patient sample when using the unicel dxh 800 coulter cellular analysis system.The customer also reported the analyzer generated "vcsn temperature not in operating range limit".A beckman coulter field service engineer (fse) was sent to the customer's facility to evaluate the system.There were no erroneous test results with this event.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

(b)(6).On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the system and confirmed the thermistor inside the peltier module was defective.The fse replaced the peltier module resolving the issue.(b)(4).

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• 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: 4004460
• MDR Text Key: 4773910
• Report Number: 1061932-2014-01892
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081930
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 629029
• Other Device ID Number: SOFTWARE VERSION: 2.0.2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• 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