MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

The application support specialist inspected the instrument and found no malfunction of the instrument.They ran 6c controls and they passed.The application support specialist stated that the cause of the issue is unknown and was isolated to one patient sample.The customer has not called to report a recurrence of the event.Bec internal identifier - (b)(4).

Event Description

The customer reported that they were having lymphocyte (ly) issues on their dxh900 hematology instrument.The instrument did not generate any messages.The initial results were reported out on (b)(6) 2022, and on (b)(6) 2022, the doctor requested a manual smear to confirm the results.The smear was provided to the doctor on (b)(6) 2022.Medication was then prescribed to the patient.There was no report of change or effect on patient treatment.There was neither death or serious injury associated with the event.

• Brand Name: UNICEL DXH 900 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: 15817369
• MDR Text Key: 303851126
• Report Number: 1061932-2022-00069
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)181221
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TN DXH 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• 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
• Patient Outcome(s): Other