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

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

A review of quarterly events indicated that for one (1) patient sample 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 one (1) patient sample tested using the galileo echo v2.0 automated blood bank system produced inaccurate results: unexpected abo typing result.On (b)(6) 2024 a customer reported that they received an unexpected abo typing results on the echo v2.0 instrument for one patient sample.Customer states that sample resulted ab pos using abodcheck2 assay on echo v2.0 instrument serial number (b)(6); but patient is historically known a pos.Customer retested the same sample with the same reagents some minutes after and resulted a pos with anti a score 4+ and anti b score 0.On (b)(6) 2024 immucor technicians used remote access to review the original results; it was verified that the sample was interpreted as ab pos with score on anti a 4+ on anti b 2+ (agglutination value 43).On march 12, 2024 an immucor field service engineer (fse) inspected echo v2.0 instrument serial number (b)(6) at the customer site.The fse proactively replaced needle and calibrated the instrument.The fse noted that that the tip of the probe was damaged, so they replace it.No patient injury or harm was reported.The immucor internal reference for the associated record is (b)(4).

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.

• 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: 19208941
• MDR Text Key: 341536184
• Report Number: 1034569-2024-00007
• 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: 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: 04/29/2024

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1