MAUDE Adverse Event Report: IMMUCOR, INC. NEO GALILEO

Model Number	0064599
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On april 30, 2021 immucor technical support used a remote electronic connection method to review results for the issue described.The roi position and flatfield were found acceptable; and there were no errors during processing.On april 30, 2021 an immucor field service engineer (fse) visited the site to inspect the instrument.The fse processed an unexpected reaction checklist and no hardware issues were found.The fse proactively replaced all sample probes to rule out any tube discoloration within the probes; and proactively replaced the wash manifold to rule out any possible malfunction.Next the fse ran all daily maintenance successfully and noted that qc processed successfully without error.The fse then ran patient samples type and screen processed with expected reactions.The immucor internal record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2021 a customer reported an unexpected negative screen with capture-r ready-screen (i and ii) lot number x522 on galileo neo serial number (b)(4).

• Brand Name: NEO GALILEO
• Common Device Name: NEO GALILEO
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 11814943
• Report Number: 1034569-2021-00015
• Device Sequence Number: 14394542
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BK200502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 0064599
• Device Catalogue Number: 0064599
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR