MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 800 HEMATOLOGY SYSTEM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no field service dispatched, the service call was cancelled by the customer.It is unknown if there were any instrument generated flags in conjunction with the event.Based on the assessment of the customer technical support representative, the event was likely caused by an aperture problem.(b)(4).
Event or Problem Description
The customer reported high platelet (plt) and low white blood cell (wbc) results were generated on patient samples on a unicel dxh 800 coulter cellular analysis system.It is unknown if there were erroneous results reported out of the laboratory.The customer re-ran samples on another instrument to identify the problem.There was no report of change or effect to patient treatment in connection with the reported event.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• MDR Report Key: 7728971
• Report Number: 1061932-2018-01034
• Device Sequence Number: 996478
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• 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
• Remedial Action: Modification/Adjustment,Repair,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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,DXH 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/28/2018
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-0730/2018-011-C
• Patient Sequence Number: 1