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

Model Number	0064599
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional serial numbers: (b)(4).Additional lot numbers: n602, ua16765897, ua 15757557, 630060.
Event or Problem Description
This report summarizes 16 malfunction events.A review of the events indicated that fourteen (14) patient samples tested on the galileo neo, automated blood bank system produced inaccurate results.A review indicated that three (3) patient sample tests using the galileo neo automated blood bank system produced an unexpected false negative result for the anti-e antibody; one (1) for the anti-c antibody; one (1) for the anti-c antibody; one (1) for the anti-jka antibody; one (1) for the anti-jkb antibody; two (2) for the anti-k antibody; one (1) for the anti-s antibody and one (1) for the anti-m antibody and one (1) for anti-d antibody.Four (4) instrument malfunctions produced inaccurate abo using the abo forward typing assay based on historical results for the patients.Subsequent testing of reagent retention lots, reviews of design history records and reagent antigen validation testing of the initial bulk product used for commercial vialing showed acceptable results.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: 10731832
• Report Number: 1034569-2020-00058
• Device Sequence Number: 3025627
• 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: 16
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2020

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: N157,N601,X513,N600,ID400,M016
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1