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

Model Number	0087000
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On march 12, 2020 immucor technical support used a remote electronic connection method to review assay records on the instrument.On march 13, 2020 an immucor field service engineer (fse) responded on site to service galileo echo v2.0 instrument serial number (b)(4).The fse performed and unexpected reaction checklist but no issues found (everything with spec).The fse proactively adjusted residual volume from 0.07 (in spec) to 0.12 and replaced a dirty rinse station filter.(b)(4).
Event or Problem Description
On (b)(6) 2020 a customer reported an unexpected negative capture-r ready-id result on the galileo echo v2.0 instrument.

• Brand Name: GALILEO ECHO
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• MDR Report Key: 9946871
• Report Number: 1034569-2020-00021
• Device Sequence Number: 16724062
• Product Code: KSZ
• UDI-Device Identifier: 10888234001584
• UDI-Public: 10888234001584
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK170132
• 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): 04/09/2020

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 Model Number: 0087000
• Device Catalogue Number: 0087000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR