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	06/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2016, the field service engineer (fse) was at the customer site and observed that the customer's lh750 had a malfunctioning check valve at vl11 and that one of the rbc aperture was not working properly.Replacement of rbc tubing and the check valve at vl11 resolved the 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.Patient information was not provided by the customer.(b)(4).Related event 1061932-2018-00039 (b)(4).
Event or Problem Description
The customer reported that their coulter lh 750 hematology analyzer was generating erroneous 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: 7988085
• Report Number: 1061932-2018-00038
• Device Sequence Number: 16250374
• 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
• Report Date (Section B): 10/20/2018

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: 06/30/2016
• Initial Report FDA Received Date: 10/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1