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

Model Number	TN, LH780 ANALYTICAL STATION
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
A field service engineer (fse) evaluated the instrument at the customer's site.The fse found that the lh780 was reporting high rbc and plt.The issue was solve by replacing 6 channel cbc pre- amp and re-routing of pinch valve tubing.Patient information not provided by the customer.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported intermittent high red blood cells (rbc) and platelet (plt) results from a coulter lh 780 hematology analyzer.The customer indicated that the samples were re-run on a backup instrument.The customer did not report erroneous patient results outside the laboratory.There was no report of change or effect to patient treatment in connection with the reported event.
Additional Manufacturer Narrative
Follow up 1: on 07-mar-2019 additional clarification was provided regarding the failure mode of this event.The field service engineer (fse) confirmed that the failed component was the 6 channel cbc pre-amp.The re-routing of the pinch valves was done as a preventive measure.Bec internal identifier: (b)(4).

• Brand Name: COULTER LH 780 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 7729043
• Report Number: 1061932-2018-01035
• Device Sequence Number: 1107408
• 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,Followup
• Report Date (Section B): 04/29/2019

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: TN, LH780 ANALYTICAL STATION
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1