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	Cancer (3262)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instrument raw data report indicates the algorithm reported a high plt count for the sample provided compared to manual review.It reported 90.5 for the first run and 3.6 for the second run.The first run had 1776 plt events in 16.2 seconds (aperture 1), but only 129 events in 19.7 seconds for the second run.The plt histograms of the first run do not show significant low-end interference, thus no correction occurred.Because higher number of plt events was collected for the first run, the algorithm reported higher plt counts than the second run.The root cause of high pseudo plt events could not be determined because the histogram shows no abnormal pattern that can caused by electrical noise/micro bubbles.Assignable cause could not be determined with the information available.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported one patient sample with multiple myeloma recovered with a high platelet (plt) count and no platelet specific suspect messaging when cycled on the dxh900 hematology instrument compared to a rerun on a different instrument and manual slide review.The higher platelet report was sent to the physician causing a delay in a platelet infusion procedure for the patient.A corrected report was sent.

• 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: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12996313
• Report Number: 1061932-2021-00173
• Device Sequence Number: 14929188
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)200504
• 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): 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/16/2021
• Initial Report FDA Received Date: 12/14/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown