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

Model Number	0064599
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	Test Result (2695)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes malfunction events.A review of the events indicated that three (3) patient samples tested on the galileo neo automated blood bank system produced incorrect abo/rh phenotype results and a false negative result for an antibody versus previous or expected results, utilizing the capture-r ready screen assay.One patient sample test on the galileo neo produced a false negative for anti-k.One patient sample test on the galileo neo missed an anti-d result after having testing positive in gel for anti-d.A third patient sample test experienced an instrument malfunction that led to an rh mistype, whereby the instrument reported rh positive while the patient was known to be rh negative.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: 9644760
• Report Number: 1034569-2020-00007
• Device Sequence Number: 1431887
• 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: 3
• 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): 01/29/2020

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: 0064599
• Device Catalogue Number: 64599
• Device Lot Number: 5030090999,R10007771,UA1598838
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1