MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	750
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	04/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2016, the field service engineer (fse) was at the customer site and observed that the customer's lh780 instrument did not have a tubing leak on he verified the flow path was not obstructed.The fse replaced the sca board, the rwip board, and the platelet processing board to resolve the reported issue it was not confirmed that patient results were impacted as a result of this event.Beckman coulter, in an abundance of caution, has submitted an mdr report.Section a patient information was not provided by the customer.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported that their coulter lh 780 hematology analyzer was generating erroneously high platelet results.It is unknown whether it was controls or patient samples that were impacted.Patient data was not provided by the customer.There was no report of change to patient treatment or affect to the patient as a result of this event.
Additional Manufacturer Narrative
On 18 april 2016, the field service engineer (fse) was at the customer site and observed that the customer's lh750 instrument did not have a tubing leak on he verified the flow path was not obstructed.The fse replaced the sca board, the rwip board, and the platelet processing board to resolve the reported issue it was not confirmed that patient results were impacted as a result of this event.Beckman coulter, in an abundance of caution, has submitted an mdr report.Section a patient information was not provided by the customer.Bec internal identifier: (b)(4).Related event 1061932-2018-0038.Follow up 01: event, brand name were revised to reflect correct instrument name.Pma/510k: pma 510k was revised to show number for correct instrument.Device manufacture date: manufacturing date has been added.
Event or Problem Description
The customer reported that their coulter lh 750 hematology analyzer was generating erroneously high platelet results.It is unknown whether it was controls or patient samples that were impacted.Patient data was not provided by the customer.There was no report of change to patient treatment or affect to the patient as a result of this event.

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 7987786
• Report Number: 1061932-2018-00039
• Device Sequence Number: 13750527
• Product Code: GKZ
• UDI-Device Identifier: 15099590264772
• UDI-Public: (01)15099590264772(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 750
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2016
• Supplement Date Received by Manufacturer: 10/21/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 10/23/2018
• Patient Sequence Number: 1