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

Model Number 0064597

Device Problems False Positive Result (1227); Non Reproducible Results (4029)

Patient Problem Test Result (2695)

Event Type  malfunction  

Event 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
• Type of Device: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 9645148
• MDR Text Key: 203695170
• Report Number: 1034569-2020-00011
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234002321
• UDI-Public: 10888234002321
• Combination Product (y/n): N
• PMA/PMN Number: BK180243
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0064597
• Device Catalogue Number: 0064597
• Device Lot Number: 5030100308,5030100343
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1