MAUDE Adverse Event Report: BECKMAN COULTER COULTER DXH DILUENT; DILUENT, BLOOD CELL

Catalog Number 628017

Device Problems Nonstandard Device (1420); Device Displays Incorrect Message (2591)

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

Event Date 08/14/2014

Event Type  malfunction  

Event Description

The customer reported obtaining platelet (plt) background failures and nucleated red blood cell (nrbc) interference flags from the unicel dxh 800 coulter cellular analysis system while using the coulter dxh diluent lot number 3510540.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

A field service engineer (fse) was dispatched to the customer's site.The fse performed troubleshooting on the unicel dxh 800 coulter cellular analysis system but the issue was not resolved.The fse then replaced the coulter dxh diluent reagent lot #3510540 with a dxh diluent reagent lot #016114k and no further issues were noted.(b)(4).

• Brand Name: COULTER DXH DILUENT
• Type of Device: DILUENT, BLOOD 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 boulevard; brea, CA 92821 ; 7149614941
• MDR Report Key: 4076076
• MDR Text Key: 21971585
• Report Number: 1061932-2014-02299
• Device Sequence Number: 1
• Product Code: GIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CLASS I EXEM
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2015
• Device Catalogue Number: 628017
• Device Lot Number: 3510540
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2050012-08/25/2014-003C
• Patient Sequence Number: 1