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
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	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported their dxh 900 instrument generated high platelet (plt) parameter results for patient samples.The instrument generated intermittent r flags and suspect messages.Erroneous results were not reported outside of the laboratory.The samples were run on an alternate instrument to obtain the correct results.Customer data was provided for patient samples reflecting erroneous high plt results along with the correct results run on an alternate instrument.The manual slide review provided for two samples agrees with the lower result from the alternate instrument.R flags and suspect messages were intermittent.Not all erroneous plt results were flagged by the instrument.
Additional Manufacturer Narrative
The applications specialist confirmed that all samples run on dxh 900 were 30-40 units higher than when run on the alternate dxh 900 instrument.The customer¿s elitech control showed positive bias for the platelet parameter.Raw data was assessed and it was noted that the area in the peak-t50 histograms has slightly more events than the other instrument used for these patient samples.They were not significant enough for the algorithm to set flags.The events in that area may be related to sweep flow interruption.It is recommended to check if the sweep flow works in optimal condition.The field service engineer (fse) went onsite replaced multiple hardware parts which did not resolve the issue.The fse replaced the entire cbc module and this successfully resolved the issue.Bec internal identifier - (b)(4).

• Brand Name: UNICEL 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 avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 17647723
• Report Number: 1061932-2023-00102
• Device Sequence Number: 6510304
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)190222
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/29/2023

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: 08/07/2023
• Initial Report FDA Received Date: 08/29/2023
• 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