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

Model Number	TN UNICEL? DXH SLIDEMAKER STAINER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no instrument malfunction.The customer scratched her right forearm with the probe wash collar while trying to remove a slide that fell inside their dxh sms instrument.The operator reported the incident as per her laboratory protocol.No further action is required at this time.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported she scratched her right forearm while trying to remove a slide that fell inside their dxh slidemaker stainer (sms) instrument.The wound on the forearm was a superficial scratch that did not require medical intervention or any work restrictions.The operator was administered retrovirals as a preventative measure and was tested for hiv and other viruses on the day of exposure.The operator was also scheduled for a 30-day follow-up.

• Brand Name: 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
• 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: 15459288
• Report Number: 1061932-2022-00061
• Device Sequence Number: 12154908
• Product Code: GKZ
• UDI-Device Identifier: 15099590192679
• UDI-Public: (01)15099590192679(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 09/20/2022

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 UNICEL? DXH SLIDEMAKER STAINER
• Device Catalogue Number: 775222
• 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: 09/09/2022
• Initial Report FDA Received Date: 09/20/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown