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

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	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported erroneous high platelets (plt) results were generated on patient samples on their dxh 800 instrument when compared to reruns on another instrument.A printout provided by the customer shows that a sample run on the instrument gave a plt result of 94 with no flags and was considered erroneous.The customer reran the sample after troubleshooting and the instrument gave a plt result of 65 which was considered correct.The erroneous results were identified before being released and did not leave the laboratory.There was no impact or change to patient treatment.There was no report of an adverse event as a result of this event.
Additional Manufacturer Narrative
The customer technical specialist (cts) verified the event via telephone what the customer reported.The cts connected to the instrument via proservice to zap the apertures, cycle the blood sampling valve (bsv) and primed the sweep flow to clean the instrument.The customer confirmed the issue was resolved.The customer reran samples that gave correct results to verify that the instrument was within specifications.Bec internal identifier: case-(b)(4).

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 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: 16243866
• Report Number: 1061932-2023-00080
• Device Sequence Number: 6454207
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)161014
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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 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: 12/29/2022
• Initial Report FDA Received Date: 01/25/2023
• 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