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

Catalog Number	0006440
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support could not use remote electronic connection method for assessment.On (b)(4) 2018 an immucor field service engineer inspected the galileo neo instrument serial number (b)(4) and found roi's in need of optimization.Fse optimized roi's successfully then reran sample with the unexpected negative and it resulted equivocal.Fse also retrieve files necessary for ts to assess camera images, event logs and result batches.Camera images are optimal and aligned, event log shows no errors during processing and specimens are acceptable based on color check images.On 19jun2018 immucor performed an antibody screen on a neo with returned sample (b)(6) (customer reports this is the same patient, the original specimen was exhausted, this sample drawn the same day) using retention capture r ready screen i, ii lot x484 and retention capture-r indicator cells lot 221113.Controls performed as expected.Return sample resulted negative with cell 1 (fya+b+) and equivocal with cell 2 (fya+b-).Cell 2 (fya+b-) appeared visually positive.Sample had exhibited 2+ hemolysis.(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, when tested on (b)(6) 2018.

• 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: 7647118
• Report Number: 1034569-2018-00162
• Device Sequence Number: 1550593
• Product Code: KSZ
• UDI-Device Identifier: 10888234000648
• UDI-Public: 10888234000648
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 102707/0.0
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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: Medical Technologist
• Device Expiration Date: 08/16/2018
• Device Catalogue Number: 0006440
• Device Lot Number: X484
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR