MAUDE Adverse Event Report: BECKMAN COULTER INC. LIPASE; LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Model Number	OSR6130
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A beckman coulter customer technical support (cts) specialist assisted customer over the phone.The customer reported when removing the outer plastic of cap, the aluminum seal did not break, making it difficult to access content of vial.Due to the difficulty of removal of seal the operator used a sharp hemostat tool to attempt to remove seal from bottle.As a result of using the sharp tool to remove difficult seal the operator sustained cuts on their middle and index finger which caused bleeding.The operator immediately wash the wound with water and applied a dressing to stop the bleeding.Due to the intense pain from injury, medical attention was required by health care professional.The operator was evaluated by health care professional and was prescribed topical ointment treatment.No additional harm was reported.The cause of the injury was identified as operator use error.The customer failed to follow precaution measures when handling the reagent bottle which resulted in injury.Per the lipase reagent osr6130 instruction for use, warning and precautions section, it states: " exercise the normal precautions required for handling all laboratory reagents." the operator missed two (2) days of work due to injury and has now recovered and returned to work.No further issues were reported.Initial reporters phone number is (b)(6).The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported an operator sustained cut injuries to index and middle fingers when attempting remove metal seal from lipase reagent bottle using sharp pointed hemostats.The customer required medical intervention due to bleeding and pain caused by the injury.The operator was evaluated by medical professional which resulted in cleaning the wound with water, dressing it, and prescription of topical ointment application to treat the wound.The operator missed two days of work due to the injury.There was no report of death associated to this event.No additional harm was reported.

• Brand Name: LIPASE
• Common Device Name: LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
• Manufacturer (Section D): BECKMAN COULTER INC.; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER IRELAND INC; lismeehan; o'callaghan's mills, co clare ; EI
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24770263
• Report Number: 9612296-2026-00150
• Device Sequence Number: 21407237
• Product Code: CHI
• UDI-Device Identifier: 15099590010270
• UDI-Public: (01)15099590010270(17)270501(11)250501(10)2699
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K963424
• 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): 04/02/2026

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: OSR6130
• Device Catalogue Number: OSR6130
• Device Lot Number: 2699
• 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: 03/04/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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: Required Intervention
• Patient Sex: Unknown