MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD BANK SYSTEM

Catalog Number	64599
Medical Device Problem Codes	False Negative Result (1225); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes malfunction events.A review of the events indicated that two (2) patient samples tested on the galileo neo automated blood bank system produced different abo/rh phenotype results versus other facilities' results or, customer tube test results.One patient sample on the galileo neo resulted in an abo phenotype of a+ versus typing of ab+ reported by two other facilities without explanation or detail regarding the two facilities.A second patient sample demonstrated a phenotype of b+ on the galileo neo with an equivocal result for anti-a.The customer's tube test produced a 1+ result for anti-a.The customer reported an a sub b result due to the results found in tube.The galileo neo's operator manual states the instrument cannot be relied upon to demonstrate hemagglutination for grade 1+ or less found in the tube methodology.Through post event tests and investigations, no specific causes were determined for the malfunctions.

• Brand Name: GALILEO NEO
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 9252151
• Report Number: 1034569-2019-00143
• Device Sequence Number: 13562735
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: BK100033
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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: 64599
• Device Lot Number: 5030090169,WU115119051091
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1