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	10/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2016, the field service engineer (fse) was at the customer site.The fse replaced the rbc (red blood cell) aperture modules, o-rings and preamp during service.The repairs were verified per established procedures.The cause of the false high plt cannot be determined.Multiple components were replaced during service.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 they are getting high platelet (plt) counts for both patient samples and controls on their coulter lh 780 hematology analyzer.There was no report of erroneous results reported out of the laboratory.There was no report of change or effect to patient treatment in connection with the reported event.Patient data was not provided by the customer for 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: 7726922
• Report Number: 1061932-2018-01009
• Device Sequence Number: 1014833
• 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): 07/27/2018

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: 10/20/2016
• Initial Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1