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

Catalog Number 178833

Device Problem Break (1069)

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

Event Date 03/02/2014

Event Type  malfunction  

Event Description

Customer reported the manual sample probe was broken on the ceramic plates (associated with the blood sampling valve) of the coulter lh 500 hematology analyzer.There was no biohazard exposure to open wounds or mucous membranes.There were no erroneous test results associated with this event.There was no death, injury or affect to patient treatment.

Manufacturer Narrative

On (b)(4) 2014, the field service engineer (fse) evaluated the instrument and found that the probe was extremely loose and while trying to take off the probe wipe, the probe fell out of the front section.The fse replaced it with a new one.The system was verified for mode to mode comparison, calibration, controls, reproducibility, startup and shutdown with no problems.(b)(4).

• Brand Name: COULTER® LH 500 HEMATOLOGY ANALYZER
• 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: 3698652
• MDR Text Key: 20322893
• Report Number: 1061932-2014-00681
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2014

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 Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• 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