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

Catalog Number 0064597

Device Problems False Negative Result (1225); False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

No common specific root cause or defect was identified.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.

Event Description

A review indicated that for three (3) patient/donor samples tested using the neo iris automated blood bank system, a malfunction occurred resulting in the instrument producing incorrect results.A review of quarterly events indicated that three (3) patient/donor samples tested on the neo iris automated blood bank system produced inaccurate results: a missed anti-e during an antibody screen; a missed weak-d; and unexpected negative results for a 2-cell screen that failed to detect a historic pan agglutin and an anti-d.On september 15, 2023 a customer reported a missed anti-e with capture-r ready-screen 3 lot number r503 (expiry september 26, 2023) on neo iris instrument serial number (b)(6).Sample was being used for a correlation study with echo lumena instrument serial number m20485; the echo lumena detected the anti-e.No patient injury or harm was reported.On september 19, 2023 an immucor field service engineer (fse) inspected neo iris instrument serial number (b)(6) at the customer site.The fse performed the unexpected reaction checklist successfully.No instrument problem was identified.The immucor internal reference for the associated record is (b)(4).On august 11, 2023 a customer reported a missed weak-d with capture-r select on neo iris instrument serial number (b)(6).Weak-d was confirmed as positive by customer on a pk instrument.Issue occurred with single donor sample; donor was previously confirmed positive for weak-d on march 17, 2022 and on january 27,2023.No patient injury or harm was reported.On august 22, 2023 an immucor field service engineer (fse) inspected neo iris instrument serial number (b)(6) at the customer site.The fse performed the unexpected reaction checklist successfully.No instrument problem was identified.On august 23, immucor performed a weak d assay on a neo iris instrument using returned donor sample and returned anti-d series 4 lot number 504037e with retention capture-r select plate lot number sc884; controls performed as expected and returned sample resulted positive.The investigation did not identify a product deficiency.The immucor internal reference for the associated record is (b)(4).On september 22, 2023 a customer reported an unexpected negative 2-cell screen using capture-r ready indicator red cells lot number 221371 on neo iris instrument serial number (b)(6).Patient had a pan agglutin and an anti-d identified in (b)(6) 2022.No patient injury or harm was reported.On (b)(6) 2023 the customer performed maintenance on neo iris instrument serial number (b)(6) at their site.Customer notes they found pin a of washer manifold with blockage, and aspiration needle slightly bent.Customer notes there were no washer errors but when flushing manifold, the dispense needle was dispensing to the side at a slower rate than other pins.The issue was resolved by the customer replacing washer manifold from customer stock.Customer successfully ran resvol and a repeat 2-cell screen with known positive sample (they received expected results in wells a and b, 3+ on both wells).The immucor internal reference for the associated record is (b)(4).

• 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: 17962464
• MDR Text Key: 326024891
• Report Number: 1034569-2023-00026
• 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: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0064597
• Device Lot Number: R503, 504037E,
• 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