MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH SLIDEMAKER STAINER II
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no impact to patients as a result of this event.The fse had a battery of tests performed for possible infectious diseases on the same day of the cut, all tests had negative results.The fse was prescribed a prophylaxis cocktail (dulotegravir sodium and tenofovir desaproxil fumarate + lumivudine).Besides the initial baseline testing, the fse will have additional testing at scheduled intervals to monitor his health.Bec internal identifier - (b)(4).
Event or Problem Description
The field service engineer (fse) reported that while working on the dxh sms instrument he received a small cut on his left thumb from a broken slide.At the time of the injury the fse was wearing personal protective equipment (ppe) which included gloves.The slide may contain biohazardous material from patient samples.

• Brand Name: UNICEL DXH SLIDEMAKER STAINER 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: 11641239
• Report Number: 1061932-2021-00058
• Device Sequence Number: 14202864
• Product Code: GKZ
• UDI-Device Identifier: 15099590701567
• UDI-Public: (01)15099590701567(11)190401
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K162414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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 SLIDEMAKER STAINER II
• Device Catalogue Number: C11477
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/09/2021
• 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