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

Model Number N/A

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and did not identify an assignable cause.As part of his trouble shooting the fse tightened the front blood detector for the blood sampling valve (bsv) and changed the actuator for valve pv10.The fse verified his troubleshooting activity as per established procedure.Weight, ethnicity, and race were not provided for the patient.Bec internal identifier (b)(4).

Event Description

The customer reported that their lh500 instrument was having reproducibility issues.The customer also reported that one level of control did not come in within range but instrument was still used to process patient samples.The customer had two patient samples that were rerun and resulted in different results from the original run.The customer also stated that the same instrument was generating a large number (5 out of 22 samples) of voteouts for rbc and mvc results.Out of the two samples that were reported as erroneous one had flagged results prompting the operator to review the results.The second patient result did not generate any flags with the results.The erroneous results were not reported out of the lab.There was no impact or change to patient treatment.

• 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, INC.; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: laurie o'riordan ; 11800 sw 147th avenue, 32-v11; miami, FL 33196-2031 ; 3053802874
• MDR Report Key: 7035671
• MDR Text Key: 92874849
• Report Number: 1061932-2017-00021
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590265045
• UDI-Public: (01)15099590265045(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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
• Patient Age: 94 YR