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

Model Number	0064597
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	Test Result (2695)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 2 malfunction events.A review of the events indicated that 2 patient samples tested on the neo iris automated blood bank system produced unexpected abo/rh or abo crossmatch phenotype results versus prior test results or, customer tube/gel test results.1 patient's crossmatch test on the neo iris resulted as compatible and should have been incompatible.The customer of neo iris made a test to validate crossmatch and screening and they had issues with 2 samples 1 instrument produced two incorrect abo/rh mistype results with forward testing.Both patients were types as ab+.Subsequent testing on the same instrument produced accurate results as a+ and b+.Through post event tests and investigations, no specific causes were determined for the malfunctions.

• Brand Name: NEO IRIS
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 9645148
• Report Number: 1034569-2020-00011
• Device Sequence Number: 1431888
• Product Code: KSZ
• UDI-Device Identifier: 10888234002321
• UDI-Public: 10888234002321
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: BK180243
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 0064597
• Device Catalogue Number: 0064597
• Device Lot Number: 5030100308,5030100343
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1