MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 600 HEMATOLOGY SYSTEM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) was at the customer site on (b)(6) 2023 to adjust the cradle setting for the customer but observed that the probe was not descending properly.The fse replaced the sampling needle resolving the issue reported by the customer.Bec internal identifier - (b)(4).
Event or Problem Description
The customer stated their dxh 600 hematology instrument reported h&h failed message and erroneous results on one pediatric sample when run in open tube mode.Low hemoglobin (hgb )results, as well as high rbc, wbc, and plt (platelet) results were produced.This instrument generated low mchc result and h&h failed user defined messages.Correct results were obtained when sample was run in closed tube mode.The erroneous results were not reported outside of the laboratory.There was no impact to patient or operator as a result of this event.Patient data was provided for the sample in question.All parameters show differences between the erroneous results generated when run in the open tube mode and the correct closed tube mode.No instrument generated flagging was observed for the erroneous results.

• Brand Name: UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 17971361
• Report Number: 1061932-2023-00109
• Device Sequence Number: 7044365
• Product Code: GKZ
• UDI-Device Identifier: 15099590192242
• UDI-Public: (01)15099590192242(11)191216
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2023

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 600 HEMATOLOGY SYSTEM
• Device Catalogue Number: B23858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown