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

Model Number	TN,DXH 800 HEMATOLOGY SYSTEM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2019, the customer service specialist (css) provided the customer guidance through the troubleshooting steps via the telephone to the satisfaction of the customer.The customer will monitor the instrument and agreed to call back if the error persisted or further assistance is needed.The customer did not call back with any additional problems, or requesting additional assistance for the alleged issue.The instrument was considered operational at the conclusion of this call.The assignable cause of the event could not be identified with the information available.Raw data was reviewed but no specific cause was identified for this event.Bec internal identifier case (b)(4).
Event or Problem Description
The customer reported that they had drawn two samples from one patient.One of the two samples generated the expected platelet (plt) based on the patient's medical history.The second sample generated an erroneously high platelet result.Both samples were run on their unicel dxh 800 coulter cellular analysis system.There was no death or injury attributed to or connected with this event there was no change in patient treatment.The results were reported outside the laboratory, to the floor nurse, who detected the inconsistency.The nurse called the lab to alert them about the results not matching.

• 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: 8960494
• Report Number: 1061932-2019-01795
• Device Sequence Number: 13975131
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: TN,DXH 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1