MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN DXH 600 HEMATOLOGY SYSTEM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not applicable.There was no impact to patients as a result of this event.One technician had a drop of retic clear reagent flick into his eye while replacing the retic pack.The technician flushed his eye with water, stating there was no irritation or vision issue.Per lab exposure protocol, went to the emergency department (ed) to have his eye checked.The ed noted no real (eye) damage and prescribed the lab tech an antibiotic.The failure mode was use error; the technician was not wearing eye protection at time of incident.The dxh series, ifu, pn: b26647ag, states the following safety notice: beckman coulter, inc.Urges its customers to comply with all national health and safety standards such as the use of barrier protection.This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer.Bec internal identifier: (b)(4).
Event or Problem Description
The customer reported while replacing the retic pack on their dxh 600 hematology instrument, the pick up tube flicked a drop of retic clear reagent into the technician¿s right eye.The technician was wearing lab coat and gloves (no face protection) at time of exposure.The technician flushed his eye with water, stating there was no irritation or vision issue.Per lab exposure protocol, went to the emergency department (ed) to have his eye checked.The ed noted no real (eye) damage and prescribed the lab tech an antibiotic.

• Brand Name: UNICEL DXH 600 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. kramer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 14596064
• Report Number: 1061932-2022-00034
• Device Sequence Number: 17531654
• Product Code: GKZ
• UDI-Device Identifier: 15099590192242
• UDI-Public: (01)15099590192242(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TN DXH 600 HEMATOLOGY SYSTEM
• Device Catalogue Number: B23858
• 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: 05/14/2022
• Initial Report FDA Received Date: 06/03/2022
• 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