MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800; COULTER CELLULAR ANALYSIS SYSTEM

Model Number	TN DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer technical support specialist (cts) recommended the customer perform the sweep flow prime procedure.The customer performed sweep flow prime three times resolving the event.Section a patient data was not provided.Bec internal identifier - case-(b)(4).
Event or Problem Description
The customer reported patient samples recovered with high platelet (plt) results and no suspect messaging when cycled on their unicel dxh800 instrument compared to a rerun on an alternate instrument.Printouts of the event were requested, but not provided.There was no report of death, injury, or change to patient treatment as a result of this event.
Additional Manufacturer Narrative
The customer technical support specialist (cts) recommended the customer perform the sweep flow prime procedure.The customer performed sweep flow prime three times resolving the event.Section a patient data was not provided.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported patient samples recovered with high platelet (plt) results and no suspect messaging when cycled on their unicel dxh800 instrument compared to a rerun on an alternate instrument.Printouts of the event were requested, but not provided.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: UNICEL DXH 800
• Common Device Name: COULTER CELLULAR ANALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA
• 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: 13544410
• Report Number: 1061932-2022-00012
• Device Sequence Number: 2162982
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/16/2022

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 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• 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: 01/24/2022
• Initial Report FDA Received Date: 02/16/2022
• 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