MAUDE Adverse Event Report: BECKMAN COULTER COULTER AC·T DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Model Number	AC*T DIFF 2
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) could not identify a malfunction with instrument or the parts that would cause the reported issue.All voltages and pressures were within specification.The fse replaced the hgb lamp and sweep flow coil as a precaution for the reported issue.The diluent and waste filter were also replaced.The fse performed instrument calibration which passed and also performed instrument to instrument verification of parameters to confirm the instrument was running properly.With the information available, the reported event could not be confirmed.In an abundance of caution beckman coulter is submitting an mdr report for this event.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported erratic hemoglobin (hgb) and platelet (plt) results for patient samples on their ac*t diff 2 instrument.Results would not reproduce on patients.There were no results reported outside of the lab.Customer is not aware of any impact to patient treatment as a result of this event.Patient data has been requested but not provided.

• Brand Name: COULTER AC·T DIFF 2 ANALYZER
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 8426702
• Report Number: 1061932-2019-01359
• Device Sequence Number: 16706675
• Product Code: GKZ
• UDI-Device Identifier: 15099590264796
• UDI-Public: (01)15099590264796(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K990352
• 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): 03/15/2019

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: AC*T DIFF 2
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/16/2019
• Patient Sequence Number: 1