MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	5diff
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2017 the field service engineer (fse) was at the customer site and observed that the check valve at vl8 was not working.The fse also replaced the hemoglobin (hgb) led, and the rbc and wbc electrodes to resolve the reported problem.It could not be confimred if there was impact to patient results for this event.In an abundance of caution beckman coulter has submitted a report.Patient information was not provided by the customer.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported that their coulter act 5diff al hematology analyzer was experiencing high platelet counts.It could not be confirmed if it was controls or patient samples that were affected.The customer did not provide patient or control data.There was no report of change of patient treatment or affect to the patient.

• Brand Name: COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 7988190
• Report Number: 1061932-2018-00040
• Device Sequence Number: 16489185
• Product Code: GKZ
• UDI-Device Identifier: 15099590576462
• UDI-Public: (01)15099590576462(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K032013
• 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

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?: No
• Operator of Device: Health Professional
• Device Model Number: 5diff
• Device Catalogue Number: 6605581
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• 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