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	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2018 the field service engineer was at the customer site and observed bubbles coming in from the fitting on the clenz input reservoir causing low mchc results.On (b)(6) 2018 the fse returned because the customer reported having low mchc results again.This visit the fse observed that in addition to the low mchc, the coulter lh 780 hematology analyzer was also generating high rbc and platelet results intermittently.The fse replaced the aspiration pump, cleaned and greased blood sampling valve (bsv) mechanism, rerouted the bsv tubing to remove possible stress points caused by the geared probe wipe assembly.Patient information was not provided by the customer.(b)(4).
Event or Problem Description
The customer reported having low mchc for patient samples on their coulter lh 780 hematology analyzer.Erroneous results were not reported outside of the laboratory.There was no change or effect to patient treatment as a result of this 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: 7708950
• Report Number: 1061932-2018-01028
• Device Sequence Number: 789710
• 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): 07/20/2018

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 Expiration Date: 03/01/2013
• Device Model Number: TN, LH780 ANALYTICAL STATION
• Device Catalogue Number: 723585
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1