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
On november 30, 2018 an immucor service technician examined neo instrument serial number (b)(4) at customer site due to customer complaint that reagent probe syringe was leaking and crystallized and that samples had returned false negative results when pipetted with pipettor #2.Upon further investigation it was identified that syringe and 3 way valve needed to be replaced due to leaking.The technician cleaned area and replaced 3 way valve and 1000ul syringe; pipettor #2 was inspected and found to be contaminated and therefore replaced.Abo qc and 3 cell qc were run and produced qualified results 12 samples were tested for abo and 3 cell screen and provided acceptable results.The instrument was operational and returned to the customer for use the immucor internal record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2018 a customer reported an unexpected negative result from capture-r ready id run on a neo instrument.

• 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: 8143178
• Report Number: 1034569-2018-00278
• Device Sequence Number: 16381178
• 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
• 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: 11/29/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1