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

Model Number 0064597

Device Problems False Negative Result (1225); False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A review of quarterly events indicated that samples tested on the neo iris automated blood bank system produced inaccurate results for known antibodies in two (2) instances (involving 2 patient samples samples); one (1) antibody id error was also reported.A customer reports donor unit mistype on neo iris serial number (b)(6).During retyping of donor units customer had run bneg units then next sequence of pipetting was opos units.First pipettor gave bpos for units that should be opos.Second pipettor gave ntd pos instead of opos.Customer repeated testing manually in tube and got o (rxn strength 0)- anti-a,b lot 301610.Customer does not perform manual anti-d testing for known rhpos units.2 units that were typing incorrectly were repeated and resulted as expected.The repeats were performed on the same instrument with the same donor units and the same reagent bottles and lots and came back o positive as expected on the second run.An immucor field service engineer replaced the reagent probe and syringe pump and the issue was resolved.A customer reported a missed ant-s on a patient sample with capture-r ready-screen (i and ii) on neo iris instrument serial number (b)(6).Sample ran on echo and resulted as anti-s.An immucor field service engineer replaced the reagent probe, syringe and valve, and the issue was resolved.A customer reported a missed anti-k with capture-r ready id on neo iris instrument serial number (b)(6).During a mini validation.Instrument setup error; auto flush had been incorrectly turned off in washer service software.An immucor field service engineer noted auto flush turned off in washer service software and turned it on.The field service engineer then adjusted the wash manifold -10 step to left from center of teach plate target, performed teach washer manifold 3x, and optimized rois using previously failed strips images; and the issue was resolved.

Manufacturer Narrative

No specific root cause or defect was identified; all relevant issues were resolve with maintenance by an immucor field service engineer.The conclusion(s) code(s) reported herein are assigned according to the facts presented by the affected customer and immucor's assessment and investigation of those facts.When possible, immucor attempts to obtain the actual samples and reagents involved; retention reagents of the same lot that was involved in the event may be used during the investigation if indicated.Also, when possible, immucor uses remote access to review the relevant data archived on the instrument.The events reported on this quarterly malfunction summary report are limited to those in which no patient harm occurred, and no design defect (or other systemic problem) was identified.There is no specific action that users are expected to take to mitigate the reported device failure/malfunction other than to ensure that preventative maintenance is performed as indicated in the instrument instructions.Immucor will continue to track and trend performance and operational issues such as described in this quarterly malfunction summary report.

• Brand Name: NEO IRIS
• Type of Device: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 16828730
• MDR Text Key: 314533423
• Report Number: 1034569-2023-00010
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234002321
• UDI-Public: 10888234002321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK180243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0064597
• Device Catalogue Number: 0064597
• Is the Reporter a Health Professional?: 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
• Patient Sequence Number: 1