MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO ECHO V2.0; AUTOMATED BLOOD BANK SYSTEM

Catalog Number 0087000

Device Problems False Negative Result (1225); False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

No common specific root cause or defect was identified.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 of quarterly events indicated that for two (2) patient/donor samples tested using the galileo echo v2.0 automated blood bank system, a malfunction occurred resulting in the instrument producing incorrect results.A review indicated that two (2) patient/donor samples tested using the galileo echo v2.0 automated blood bank system produced inaccurate results: a missed anti-c and anti-e from same sample during an antibody screen; and an unexpected weak-d positive for a patient with no previous history of weak-d.On september 28, 2023 a customer reported missed anti-c and anti-e from same sample with capture-r ready-screen 3 lot number r517 (expiry october 24, 2023) and capture-r ready indicator red cells lot number 221379 on galileo echo v2.0 instrument serial number (b)(6).No patient injury or harm was reported.Immucor confirmed the c antigen on all c positive cells and the e antigen on all e positive cells on returned capture-r ready-screen 3 lot number r517 by capture method using retention anti-c, retention anti-e and retention capture-r ready indicator red cells lot number 221379: controls performed as expected; all c positive cells resulted positive with retention anti-c and all e positive cells resulted positive with retention anti-e; all c negative and e negative cells resulted negative as expected.Returned product performed as expected.No specific reagent or instrument problem was identified.The immucor internal reference for the associated record is (b)(4).On august 29, 2023 a customer reported an rh mis-type: unexpected weak-d positive with anti-d (lot 504055) on galileo echo v2.0 instrument serial number (b)(6).Patient tested as a negative then had a positive weak-d on (b)(6) 2023, no previous history before that.No patient injury or harm was reported.The customer resolved the issue on august 7, 2023 by cleaning the manifold.Instrument is operating as expected and currently in customer use.The immucor internal reference for the associated record is (b)(4).

• Brand Name: GALILEO ECHO V2.0
• 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: 17962463
• MDR Text Key: 326036106
• Report Number: 1034569-2023-00027
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234001584
• UDI-Public: 10888234001584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170132
• Number of Events Reported: 2
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0087000
• Device Lot Number: R517, 221379
• 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