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

Catalog Number 178833

Device Problems Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591); Data Problem (3196)

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

Event Date 04/20/2014

Event Type  malfunction  

Event Description

The customer reported one patient sample run on their lh500 instrument gave an erroneous high platelet (plt) result of 709k with an instrument generated flag.The customer noticed the plt result did not match patient history and reran the same sample the next day where the plt result was lower (217k) and considered correct as it was closer to previous results.There was no death, injury or change to patient treatment attributed to this event.No other samples were affected.

Manufacturer Narrative

A field service engineer (fse) was dispatched.The fse cleaned the red blood cell (rbc) aperture housing and replaced the rbc aperture and o-rings, primed sweep flow line, ran startup and several samples to verify normal operation.He ran latron and 5c controls, all were within specification.(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: 3809402
• MDR Text Key: 19584632
• Report Number: 1061932-2014-01064
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/21/2014

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: 04/21/2014
• Initial Date FDA Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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