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	09/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) visited the customer site on 23 sep 2017 and found that the rbc diluent pump was broken.The fse replaced the rbc diluent pump and the high plt issue was resolved.The fse verified the repairs.Section a - patient information not provided by the customer.Beckman coulter is conducting a retrospective review of its global service records, to ensure that the records had been adequately evaluated for potential complaint information and any warranted follow-up action, including mdr reporting.This mdr report is a result of that retrospective review.(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 stated the repeat runs did not correlate.The customer did not report patient results outside the laboratory.There was no report of change or effect to patient treatment in connection with the reported event.

• 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: 7726990
• Report Number: 1061932-2018-01022
• Device Sequence Number: 11039617
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/27/2018

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: TN, LH780 ANALYTICAL STATION
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2017
• Initial Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1