MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 780 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	780
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per phone conversation with the field service engineer (fse) on june 13, 2018 he indicated that the cause of the erroneous results and flags was a kinked tube, he did not see any evidence of the system diluting the sample.Pro-service data revealed that the system gave partial aspiration and diluted sample messages on (b)(6) at 10:54 a.M.Per the subject matter expert (sme), the failure mode identified can be related to a dirty blood sampling valve (bsv).This has the potential of false high elevated plt results due to cbc segmentation error.The data suggests this may have occurred.Although the reports were not sent out of the lab, it cannot be disregarded that the failure could have contributed to erroneous high plt.The fse found that the waste tubing at port 201 of the blood sampling valve (bsv) kinked.The fse rerouted the tubing to remove a kink.Resolving the reported issue.Patient information: were not provided by the customer.(b)(4).
Event or Problem Description
The customer reported that their coulter lh 780 hematology analyzer was diluting patient samples and generating erroneous results.The customer had observed there was fluid on top of the fluid caps after piercing and that sample results were erratic.36 patient reports of the initial sample results were provided.The qc controls had run as expected.The customer indicated that they reran the samples but considered them to be already diluted and did not send the reports.They left the decision for patient redraws at the discretion of the medical practitioner.The customer, upon reviewing the results for the redraw of patient id (b)(6), found that the platelet results had a lower value than the original run.

• Brand Name: COULTER LH 780 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea FL 92821
• MDR Report Key: 8005297
• Report Number: 1061932-2018-01048
• Device Sequence Number: 16490426
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K061616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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: 780
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/22/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 10/25/2018
• Patient Sequence Number: 1