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 (3) donor samples.On october 26, 2023 a customer reported that they received an unexpected abo typing results on the neo iris instrument for one donor sample (the actual date of the event was not provided).Customer states that sample from a donor who is historically a pos was reported as ab pos using anti-b lot number 203930 with thermo scientific lot number 676110 prebuffered saline on neo iris instrument serial number (b)(6).Customer repeated testing manually with the same reagent lots/different vials and resulted a pos as expected.Customer repeated sample on neo iris instrument serial number (b)(6) and it resulted a pos as expected.Issue was potentially caused by reagent splashing during dispense (indicated by customer but not verified).On (b)(6) 2023 immucor used remote access to review images of the affected plate; reagent dispensed into wells did not appear to have been dispensed directly in the center.Immucor reviewed multiple plates tested that day and did not observe any others with splashing issues.No patient injury or harm was reported.The immucor internal reference for the associated record is (b)(4).On october 10, 2023 a customer reported that they received an unexpected abo typing results on the neo iris instrument for one donor segment sample.Customer states that sample from a donor who is historically o pos was reported as b pos on neo iris instrument serial number (b)(6).Customer repeated testing manually resulted o pos as expected.On october 23, 2023 customer repeated testing with new sample on neo iris instrument serial number (b)(6) and it resulted o pos as expected.On october 26, 2023 immucor used remote access to review images of the affected plate; flatfield appeared to be acceptable, but red cells debris was observed on the plate in question.Unable to rule out if tiny amount of fibrin or clot was present from original segment.No patient injury or harm was reported.The immucor internal reference for the associated record is (b)(4).On november 29, 2023 a customer reported that they received an unexpected abo typing results on the neo iris instrument for one donor sample.Customer states that sample from a donor who is historically a pos was reported as ab pos using anti-b lot number 203931 (expiry february 27, 2025) on neo iris instrument serial number (b)(6).Customer repeated testing on (b)(6) 2023 and resulted as ntd pos (forward type was a pos but reverse type was negative with a1 cell and b cell).Customer typed donor manually in tube and resulted as a positive.No patient injury or harm was reported.Immucor performed an aborh assay on the neo iris using in house donor samples with known aborh types.Testing included the use of retention anti-b lot number 203931; all in house samples resulted as expected for their respective aborh type.Immucor performed an aborh assay on the neo iris using returned donor samples with retention anti-b lot number 203931; samples resulted a positive as expected.On (b)(6) 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).

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: 18616554
• MDR Text Key: 335096708
• Report Number: 1034569-2024-00002
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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
• 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