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

Model Number TN DXH 600 HEMATOLOGY SYSTEM

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 326314375
• Report Number: 1061932-2023-00109
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590192242
• UDI-Public: (01)15099590192242(11)191216
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1