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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.The printout received indicated one patient sample recovered with lower neutrophils and higher monocytes with suspect messaging (immature granulocytes, left shift, lymphocyte blast, monocyte blasts, variant lymph) compared to a manual slide review.The customer reported the instrument result out of the lab and did not perform a manual smear confirming the results previous to their release.The patient was administered an unnecessary cerebral spinal fluid (csf) procedure as a result of the released results.The customer did a smear review of the results at a later time and the procedure had been completed by that time.The application specialist (cts) verified the event via pro service and collected raw data.The raw data report indicated the sample received shows left shifted neutrophil population that falls in monocyte region.The algorithm classified them as monocytes as it is designed.The root cause of the left shifting of the population could not be determined because of lack of information.The algorithm set blast, imm gran, variant lymph and left shift flags because of abnormal patterns in the histogram plots.When the algorithm sets suspect flags, it is recommended results be reviewed appropriate to the patient population and laboratory practices (dxh800 ifu 6-42).The instrument was not serviced and is operational.Bec internal identifier (b)(4).
Event or Problem Description
The customer reported one patient sample run on the dxh900 hematology instrument recovered with erroneous low neutrophil and high monocyte result with suspect messaging compared to a manual slide review.The patient was administered an unnecessary cerebral spinal fluid (csf) procedure due to the event.The report was corrected after the procedure was completed.There was no death or permanent injury associated with this incident.

• 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
• MDR Report Key: 11311994
• Report Number: 1061932-2021-00021
• Device Sequence Number: 14380600
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)181019
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other