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

Model Number	0064597
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A review of the events indicated that patient samples tested on the neo iris, automated blood bank system produced inaccurate results.A review indicated that patient sample tests using the neo iris automated blood bank system produced one (1) false negative result for the anti-e antibody; one (1) false negative result for the anti-k antibody and one (1) false negative for the anti-fya antibody.Three (3) instrument malfunctions produced inaccurate abo using the abo forward typing assay based on a historical result for the patient; inaccurately typing anti-d, anti-a and anti-b.Subsequent testing of reagent retention lots, reviews of design history records and reagent antigen validation testing of the initial bulk product used for commercial vialing showed acceptable results.No single reason for the false negatives were determined and the malfunctions were allocated against the analytical instrument.
Additional Manufacturer Narrative
Additional serial number (b)(4).

• Brand Name: NEO IRIS
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM, PRODUCT CODE:KSZ
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway dr; norcross GA 30091 5625
• Manufacturer Contact: howard yorek ; 3130 gateway dr.; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 13398045
• Report Number: 1034569-2022-00002
• Device Sequence Number: 6090994
• Product Code: KSZ
• UDI-Device Identifier: 10888234002321
• UDI-Public: 10888234002321
• Combination Product (Y/N): N
• PMA/510(K) Number: BK210560
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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: Health Professional
• Device Model Number: 0064597
• Device Catalogue Number: 0064597
• Device Lot Number: 924675,ID423,SC776,R319
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown