MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 178833

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem Not Applicable (3189)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument on (b)(6) 2015.The fse found that solenoid 5 was not working and was failing to actuate pinch valve pv3.The fse replaced the solenoid, which resolved the wbc issue.The repairs were verified by the fse.(b)(4).

Event Description

The customer reported the coulter lh 500 hematology analyzer gave no white blood cell (wbc) result for one patient sample.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

(b)(4).

• Brand Name: COULTER LH 500 HEMATOLOGY ANALYZER
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 south kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th ave; 32-s08; miami, FL 33196 ; 3053802031
• MDR Report Key: 5250484
• MDR Text Key: 32301633
• Report Number: 1061932-2015-01763
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042724
• 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: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• 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