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

Model Number	TN,DXH 800 HEMATOLOGY SYSTEM
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	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the result printouts provided by the customer shows the reported elevated plt result, backlit and ch flagged (high critical limit exceeded) on initial run, along with delta check trigger prompting the operator to review the result.The sample was rerun twice, the third run was released as correct.The field service engineer (fse) found the sweep flow check valve malfunctioned and observed microbubbles in the sweep flow pathway causing the elevated erroneous plt result.The fse replaced the sweep flow check valve and re-tubed the sweep flow pathway.Due to cracked fitting, the retic clear chamber was preventively replaced.The flow cell was cleaned/flushed, and instrument pressures adjusted on system monitor screen.The fse verified and validated the system by performing daily checks, latron, and 6c controls, all within specifications.No other issues were found.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported their dxh800 instrument gave an erroneous elevated platelet (plt) result for one specific patient compared to same sample rerun, manual estimate and delta check.The customer technical support (cts) confirmed erroneous results were not reported out of the lab, no other samples were impacted, and qc was within specification at time of event.There was no report of death, injury, or change to patient treatment as a result of this event.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer; brea CA 92821
• MDR Report Key: 12278586
• Report Number: 1061932-2021-00093
• Device Sequence Number: 11702513
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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?: No
• 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: 07/06/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1