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	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 9 nov 2016, the field service engineer (fse) was at the customer site and inspected the lh780 instrument but was not able to find an instrument malfunction.The fse replaced tubing and cleaned the instrument as preventive maintenance.The fse verified that the instrument was working per specifications.The failure mode is unknown.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 is generating high platelet (plt) results.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: 7726898
• Report Number: 1061932-2018-01015
• Device Sequence Number: 16397630
• Product Code: GKZ
• UDI-Device Identifier: 15099590282431
• UDI-Public: (01)15099590282431(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 11/09/2016
• Initial Report FDA Received Date: 07/27/2018
• Patient Sequence Number: 1