MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEMS

Catalog Number	0064599
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019 immucor technical support used a remote electronic connection method to assess files on galileo neo instrument serial number (b)(4); roi's were acceptable and no errors were seen during times of testing.On (b)(6) 2019 an immucor field service technician inspected galileo neo instrument serial number (b)(4) at the customer facility.The technician found the instrument operational and performed a successful unexpected reaction checklist.Found instrument to be fully operational and to be operating in specification.Customer was informed that unable to rule out the possibility that the original vials of anti-d (monoclonal blend) series 4 and anti-d (monoclonal blend) series were compromised.The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported rh discrepancies when testing donor samples on the galileo neo instrument.

• Brand Name: GALILEO NEO
• Common Device Name: AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEMS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8860787
• Report Number: 1034569-2019-00125
• Device Sequence Number: 13906125
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: BK190337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: 07/11/2019
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1