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	03/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 25-mar-2016 the field service engineer (fse) was at the customer site and observed that the reported issue was occurring in manual mode.The fse took apart and cleaned the bsv (blood sampling valve) to resolve the issue.The repairs were verified per established procedures.The cause of the high plt results is attributed to an obstructed bsv.Section a - patient information was 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 that their coulter lh 780 hematology analyzer was generating erratic platelet (plt) results and the controls were also biased high for platelets.The customer had not reported any erroneous results outside of the laboratory.There was no report of change or effect to patient treatment in connection with the reported event.The issue was reported as an ongoing issue for a two week period by the customer but they had not called to report it previous to this call.

• 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: 7726875
• Report Number: 1061932-2018-01008
• Device Sequence Number: 1315916
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: No Information
• 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: 03/16/2016
• Initial Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1