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

Catalog Number 178833

Device Problems Fluid/Blood Leak (1250); Temperature Problem (3022)

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

Event Date 06/04/2014

Event Type  malfunction  

Event Description

The customer reported approximately 5 mls of diluent leaked from the bottom of the sweepflow reservoir inside the coulter lh 500 hematology analyzer.The customer stated that the instrument generated temperatures errors with erroneous and exceeded linearity for white blood cell (wbc) and hemoglobin (hgb) results on four patient samples.The leak was not contained within the instrument.The customer was wearing personal protective equipment (ppe) consisting of gloves, goggles, and a lab coat at the time of the occurrence.There was no exposure to open wounds or mucous membranes.There were no erroneous results reported out of the laboratory.There was no death, injury, or affect to user or to patient treatment attributed to this event.

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to assess the instrument.The fse confirmed the leak from the bottom tubing that disconnected from the sweepflow reservoir.However, the customer replaced the tubing and the associated check valve prior to the fse's arrival, resolving the leak.The fse observed the leak had damaged the peltier module.The fse replaced the peltier module, resolving the temperature errors and incomplete differential (diff) results.The fse suspected the leak had also wet pinch valve (pv7) during the event causing the pinch valve (pv7) not to open properly and generating erroneous white blood cell (wbc) and hemoglobin (hgb) results.However, it was dried and working properly when the fse verified instrument operation.The instrument was returned to normal operation.The customer provided printouts with erroneous and correct results on one patient sample (sample 4) and provided printouts of erroneous results only on three patient samples.The printouts indicated that sample 4 recovered with wbc voteouts, erroneous high hemoglobin (hgb), mean cell volume (mcv) and mean corpuscular hemoglobin (mch) results, and an incomplete absolute differential count with suspect messaging on two reruns compared to the initial run of the sample.Sample1 recovered with exceeded linearity for wbc and hgb count with suspect messaging.Sample 2 recovered with incomplete results for all parameters on the initial run and exceeded linearity result for the wbc and hgb result with incomplete differential results and suspect messaging on the rerun.Sample 3 recovered with exceeded for wbc and hgb result with an incomplete differential result and suspect messaging on the initial run.The rerun of sample 3 recovered with a wbc voteout, exceeded linearity for hgb result and an incomplete absolute differential result with suspect messaging.

• 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: 3914649
• MDR Text Key: 4584393
• Report Number: 1061932-2014-01568
• 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: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 178833
• Other Device ID Number: SW VERSION: 2A6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/01/2010
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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