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

Catalog Number	0064599
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method to assess the testing instrument in question on 29sep2018, which showed an atypical image for the a1 reverse cells as a 2+ positive.No events were noted in the error log.The internal immucor record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an abo mistype when tested on a galileo neo instrument, when tested on (b)(6) 2018.

• 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: 7966149
• Report Number: 1034569-2018-00225
• Device Sequence Number: 148895
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK100033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 0064599
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1