MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO ECHO V2.0; AUTOMATED BLOOD BANK SYSTEM

Catalog Number	0087000
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Transfusion Reaction (4596)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On august 31, 2023 immucor technicians used remote access to review the results of screening results from (b)(6) 2023 and (b)(6) 2023; review of the camera report and event log showed no issues.On (b)(6) 2023 an immucor field service engineer (fse) inspected echo lumena instrument serial number (b)(6) at the customer site.The fse performed an unexpected reactions checklist and discovered the 1ml syringe had an increased amount of friction; 1ml syringe was proactively replaced using on site stock.The fse the initialized instrument and ran daily maintenance, performed group screen qc (with expected results), and ran the discrepant sample.The instrument was tested and returned to customer.No further investigation is possible as no patient sample or product was returned to immucor, and no further information was provided by the customer.The internal immucor record for this event is (b)(4).
Event or Problem Description
On (b)(6) 2023 a customer reported that a patient had a hemolytic transfusion reaction.

• Brand Name: GALILEO ECHO V2.0
• 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: 17795777
• Report Number: 1034569-2023-00024
• Device Sequence Number: 2236182
• Product Code: KSZ
• UDI-Device Identifier: 10888234001584
• UDI-Public: 10888234001584
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK170132
• 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): 09/21/2023

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: 0087000
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/21/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male