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

Catalog Number	0064599
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019 immucor technical support used a remote electronic connection method to transfer camera images, event logs and result batches for the issue described.Review of the event log showed no errors during testing and review of the rois show that they are not misaligned.Review of the plate showed that donor c055619628551 was graded as negative (visually, wells a01 and b01 appear negative, with no red cell adherence).On (b)(6) 2019 an immucor field service engineer examined the instrument at the customer site.The instrument was found to be within specifications.The fse completed the unexpected reactions checklist.Kell qc and samples ran okay, but the sample in question was too old to be repeated.Unable to rule out the sample as the cause of the unexpected negative result.The immucor internal record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported an unexpected negative for a phenotyping assay 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: 9564566
• Report Number: 1034569-2020-00003
• Device Sequence Number: 3229933
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK100033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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: 12/23/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1