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

Model Number TN UNICEL? DXH SLIDEMAKER STAINER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/09/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 300297119
• Report Number: 1061932-2022-00061
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590192679
• UDI-Public: (01)15099590192679(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other