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); 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 3 malfunction events.A review of the events indicated that three (3) patient samples tested on the galileo neo automated blood bank system produced unexpected abo/rh or abo crossmatch phenotype results versus prior test results or, subsequent manual tube/gel test results.One (1) patient's crossmatch test on the galileo neo resulted as compatible and should have been incompatible, given the patient's sample was anti-c and the donor sample was c+.One (1) test produced an abo/rh forward testing mistype result due to a false positive result of b positive; whereby historical results determined a phenotype of ab positive.One (1) galileo neo result was incorrect with a b+ result instead of an ab+ result.The galileo neo resulted the donor as b positive.The donor blood was retested in a reference lab and resulted as ab positive.The donor blood was not used and returned after testing by the reference lab.Tube interpretation resulted as asubb positive, with an anti-a result of 1+.Galileo neo's operation manual provides limitations whereby, the neo cannot reliably detect hemagglutination reactions graded as 1+ or less in test 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
• MDR Report Key: 10016362
• Report Number: 1034569-2020-00025
• Device Sequence Number: 11378133
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (Y/N): N
• 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): 04/30/2020

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: UA16044583,203820,SC649
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1