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

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

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

Event Type  malfunction  

Event Description

A review indicated that for three (3) 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) donor samples tested on the neo iris automated blood bank system produced inaccurate results: abo mistype for three (2) donor samples; and unexpected anti-c for one (1) donor unit.On (b)(6) 2024 a customer reported that they received an unexpected negative anti-c result on the neo iris instrument for one donor sample.Customer states that sample from a donor was reported as negative using anti-c lot number 936235 on neo iris instrument serial number (b)(6).Customer states that they repeated sample using anti-c lot 936225 and got ntd on on neo iris instrument serial number (b)(6); customer states that they resuspended and respun sample and repeated again and still resulted as ntd.Repeat testing in reference lab identified c+ in sample.On (b)(6) 2024 immucor used remote access to review images of the affected plate; flatfield was acceptable.On (b)(6) 2024 an immucor field service engineer (fse) inspected neo iris instrument serial number (b)(6) at the customer site.The fse performed an unexpected reaction checklist successfully.The fse observed that the valves for probes 1 and 2 were damaged and replaced those valves.No patient injury or harm was reported.The immucor internal reference for the associated record is pr#(b)(4).On (b)(6) 2024 a customer reported that one known b positive donor unit was called ab positive on the neo iris instrument.Customer states that sample from a donor was reported as ab positive using anti-a lot number 101091 on neo iris instrument serial number (b)(6).Customer performed tube testing to confirmed donor type was b positive.On (b)(6) 2024 immucor used remote access to review images of the affected plate; flatfield was acceptable and results for anti-a wells visually appeared as positive.On (b)(6) 2024 an immucor field service engineer (fse) inspected neo iris instrument serial number (b)(6) at the customer site.The fse performed an unexpected reaction checklist successfully.The fse replaced reagent pipettor, 3 way valve, and rinse pump before returning the instrument to service.No patient injury or harm was reported.The immucor internal reference for the associated record is pr#(b)(4).On (b)(6) 2024 a customer reported that one known ab negative donor unit was called b negative on the neo iris instrument.Customer states that on (b)(6) 2024 sample from a known ab negative donor unit was called b negative using anti-a (mono) series 1 lot number 101071e on neo iris instrument serial number (b)(6).Customer then ran the sample on a grifols erytra on (b)(6) and got ab negative as expected with 2+ reactivity on anti-a cells.In tube customer got b negative the first time but on repeat in tube was ab negative; the reaction strength was w+ to 1+ via tube methodology.On (b)(6) 2024 immucor used remote access to review images of the affected plate; no errors during processing, qc passed without issue, full plate ran, all other sample resulted as expected.Immucor technical services advised the customer that issue may be sample related and reminded them of the label limitation that the neo iris cannot reliably detect hemagglutination reactions that are graded as 1+ or less in test tube methodology.No patient injury or harm was reported.The immucor internal reference for the associated record is pr#(b)(4).

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.

• 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 30071
• MDR Report Key: 19208881
• MDR Text Key: 342090939
• Report Number: 1034569-2024-00006
• 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: 04/26/2024

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1