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

Model Number	N/A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• MDR Report Key: 7035671
• Report Number: 1061932-2017-00021
• Device Sequence Number: 1677307
• Product Code: GKZ
• UDI-Device Identifier: 15099590265045
• UDI-Public: (01)15099590265045(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1