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

Catalog Number 628017

Device Problems Nonstandard Device (1420); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

The customer reported platelet background high failures on the unicel dxh 800 coulter cellular analysis system when using a specific lot number of coulter dxh diluent.There were no erroneous test results with this event.There was no death, injury or affect to user or patient treatment.

Manufacturer Narrative

The customer replaced coulter dxh diluent lot number 3510440 with coulter dxh diluent lot number 3510620 and the platelet background counts were acceptable.(b)(4).

Manufacturer Narrative

Further evaluation of the reported malfunction was conducted.The dxh 800 diluent lot number 3510440 was determined to be excluded from 2050012-08/25/2014-003c, an action reported under 21 usc 360i(f).The cause of the reported event, elevated background count for the platelet parameter, was not determined and was resolved by the customer in accordance with product labeling.

• Brand Name: COULTER DXH DILUENT
• Type of Device: BLOOD CELL DILUENT
• 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: 4070036
• MDR Text Key: 4897071
• Report Number: 1061932-2014-02286
• Device Sequence Number: 1
• Product Code: GIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/11/2014

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: 12/11/2015
• Device Catalogue Number: 628017
• Device Lot Number: 3510440
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2014
• Initial Date FDA Received: 09/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2014
• 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