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

Catalog Number	0064599
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Fever (1858)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method to assess the testing instrument in question on 21nov2018, which showed test well images in question as visually negative.The review of the event log showed no errors during processing.The roi images appeared acceptable and the flatfields were acceptable.An immucor field service engineer (fse) visited the customer site to assess the testing instrument on (b)(6) 2018 and determined that the residual volume was slightly high out of specification with a value of 0.84.The fse adjusted that residual volume to within specification with a value of 0.52.The fse performed teach washer and the instrument subsequently passed qc.The internal immucor record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2018, a customer site reported an unexpectedly negative antibody screen when tested on a galileo neo instrument, which was involved in a transfusion reaction investigation.

• Brand Name: GALILEO NEO
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8152528
• Report Number: 1034569-2018-00279
• Device Sequence Number: 11310117
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK100033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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 Catalogue Number: 0064599
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR