MAUDE Adverse Event Report: BECKMAN COULTER IRELAND 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	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The field service engineer (fse) observed that the rbc bath was faulty, causing the reported event.The fse replaced the bath resolving the issue.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported thrombocytopenic patient samples recovered with higher platelet (plt) results when cycled on their dxh 800 hematology instrument (dxh800-3) compared to alternate dxh800 instruments.There was no report of an adverse event.There was no report of erroneous patient results reported outside the laboratory.There was no impact to patient treatment.Printouts received indicated one patient sample (sample 1) recovered with higher platelet results from the dxh800-3 compared to a rerun on an alternate instrument the customer believes to be correct.No suspect messaging on either run.Printouts also received indicated two patient samples (sample 2 and sample 3) recovered with higher platelet results from the dxh800-3 compared to reruns on alternate instruments the customer believes to be correct.It is unknown if either run recovered with suspect messaging.The next set of printouts received indicated one patient sample (sample 4) recovered with higher platelet results from the dxh800-3 compared to a rerun on an alternate instrument the customer believes to be correct.Both runs recovered with suspect messaging.The last printouts received (sample 5) recovered with higher platelet results and suspect messaging from the dxh800-3 compared to a rerun on an alternate instrument the customer believes to be correct.All other parameters correlated between runs on all samples.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER IRELAND; 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: 14186889
• Report Number: 1061932-2022-00023
• Device Sequence Number: 5755950
• Product Code: GKZ
• UDI-Device Identifier: 15099590381646
• UDI-Public: (01)15099590381646(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/22/2022

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 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• 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: 03/25/2022
• Initial Report FDA Received Date: 04/22/2022
• 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