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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The available information reasonably suggests the reported issue was a use error.The fse placed a paper towel underneath the aspiration probe while it was in motion piercing his finger.Bec internal identifier case: (b)(4).
Event or Problem Description
A beckman coulter field service engineer (fse) punctured his finger on the piercing probe of a customer's unicel dxh 900 coulter cellular analysis system while servicing it.The fse went to the customer lab site for a leaky dxh900 aspiration probe.While addressing the leak, the fse placed a paper towel underneath the aspiration probe while it was in motion.The fse stated he had done this procedure before and thought he had a few more seconds, the probe extended and pierced his left index finger.The fse went to the emergency room where blood was drawn to screen for (b)(6).Baseline testing was performed; the first blood results came back b)(6).The fse will be scheduling two follow up appointments at 6 weeks and 6 months for his second and third round of (b)(6) shots.The fse reported he is healthy and able to continue with work.

• 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: 10973328
• Report Number: 1061932-2020-00176
• Device Sequence Number: 791460
• Product Code: GKZ
• UDI-Device Identifier: 15099590701574
• UDI-Public: (01)15099590701574(11)191014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/08/2020
• 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