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

Catalog Number B24802

Device Problems Nonstandard Device (1420); Output below Specifications (3004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

The customer reported they noticed a downward trend (within specification) for hemoglobin (hgb) results on controls only on a unicel dxh 800 coulter cellular analysis system when compared to their other dxh800 instrument and service was dispatched.Controls for all parameters were reported to be within the acceptable range.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.

Manufacturer Narrative

A field service engineer (fse) evaluated the instrument on 05/08/2015 and confirmed that the hgb cuvette appeared slightly cloudy.The fse cleaned the hgb cuvette and after cleaning it, the hgb on controls shifted back up closer to the target value.(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: miranda holland ; 11800 sw 147th avenue, 32-l23; miami, FL 33196-2031 ; 3053802031
• MDR Report Key: 4805896
• MDR Text Key: 5832404
• Report Number: 1061932-2015-00899
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/08/2015

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 Catalogue Number: B24802
• Other Device ID Number: SOFTWARE VERSION: 3.0.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 2050012-04/20/2015-001C
• Patient Sequence Number: 1