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

Model Number	TN DXH 900 HEMATOLOGY 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	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported, three patient samples recovered with high platelet (plt) results when cycled on their dxh900 instrument.Two patient samples recovered with suspect messaging.One patient sample did not.There was no report of death, injury, or change to patient treatment as a result of this event.Printouts received, indicated one patient sample (sample 1) recovered with low wbc, rbc, hematocrit (hct) and high platelet (plt) results, compared to a redrawn sample two days later the customer believes to be correct.Printouts also received, indicated a second patient sample (sample 2) recovered with low wbc, rbc, hemoglobin (hgb) and hct results along with high mean corpuscular hemoglobin (mch).Mean corpuscular hemoglobin concentration (mchc) and plt results with suspect messaging compared to a redrawn sample two days later the customer believes to be correct.The last printouts received, indicated a third patient sample (sample 3) recovered with low wbc, rbc, hct results along with high mch, mchc and plt results, and suspect messaging compared to a redrawn sample two days later the customer believes to be correct.
Additional Manufacturer Narrative
The customer technical specialist (cts ) assisted the customer via telephone and explained the instrument limitations related to high platelet results.During a second conversation with the customer a few days following the event, it was verified the high platelet results for initial draws on the questioned patient samples was related to hemolysis during the blood collection process.A review of subsequent service reports does not show any further contact with beckman coulter for instrument or patient problems.The samples in question were hemolyzed.Bec internal identifier: (b)(6).

• Brand Name: UNICELL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th ave; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16773277
• Report Number: 1061932-2023-00089
• Device Sequence Number: 16956816
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)190715
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/19/2023

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 900 HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: C11478
• 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: 03/28/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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