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

Catalog Number 64599

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This is an amendment to medwatch 1034569-2023-00016; this quarterly malfunction report has been amended to include the previously omitted data required in section h1.No specific root cause or defect was identified; all relevant issues were resolved with maintenance by an immucor field service engineer.The conclusion(s) code(s) reported herein are assigned according to the facts presented by the affected customer and immucor's assessment and investigation of those facts.When possible, immucor attempts to obtain the actual samples and reagents involved; retention reagents of the same lot that was involved in the event may be used during the investigation if indicated.Also, when possible, immucor uses remote access to review the relevant data archived on the instrument.The events reported on this quarterly malfunction summary report are limited to those in which no patient harm occurred, and no design defect (or other systemic problem) was identified.There is no specific action that users are expected to take to mitigate the reported device failure/malfunction other than to ensure that preventative maintenance is performed as indicated in the instrument instructions.Immucor will continue to track and trend performance and operational issues such as described in this quarterly malfunction summary report.

Event Description

A review indicated that one (1) donor sample test using the galileo neo automated blood bank system malfunctioned, resulting in the instrument producing incorrect results.A review of quarterly events indicated that patient samples tested on the galileo neo automated blood bank system produced inaccurate results for abo phenotyping in one (1) instance (involving 1 donor samples).A donor sample (from a packed red blood cell unit) unexpectedly resulted b-positive with forward group testing on galileo neo instrument serial number (b)(6).Repeat testing on the same instrument (with the same reagents), and manual testing both resulted o-positive as expected.Issue was resolved after service by an immucor field service engineer (fse).Fse found imbalance spring on centrifuge broken and proactively replaced probe, syringe, and 3-way valve on probe #3 due to discoloration.No adverse event occurred.No incompatible blood products were transfused.The immucor internal reference for the associated record is (b)(4).

• Brand Name: GALILEO NEO
• Type of Device: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 17431210
• MDR Text Key: 320369944
• Report Number: 1034569-2023-00020
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK100033
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 64599
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1