MAUDE Adverse Event Report: IMMUCOR, INC. ECHO LUMENA; AUTOMATED BLOOD BANK SYSTEM

Catalog Number	0086998
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On february 20, 2026 a customer reported that technician was injured while replacing the syringe of echo lumena instrument serial number (b)(6).Customer has stated that the event was reported for documentation purposes only.
Additional Manufacturer Narrative
No injury follow up was provided by the customer.No serious or permanent injury or harm was reported related to instrument malfunction.The specific instrument was inspected for potential defects of the fluidics module cover and hinge assembly by customer after the event and was found to be working as expected.No specific instrument defect or malfunction was identified.There have been no events of a similar nature reported for the echo lumena instrument.There is no specific action that users are expected to take to mitigate the reported device failure/malfunction other than to ensure that preventative maintenance is performed as indicated in the instrument instructions.The immucor internal reference number for this event is pr # (b)(4).

• Brand Name: ECHO LUMENA
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 24658804
• Report Number: 1034569-2026-00012
• Device Sequence Number: 13072264
• Product Code: KSZ
• UDI-Device Identifier: 10888234002338
• UDI-Public: 10888234002338
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK070016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2026

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 Catalogue Number: 0086998
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Female