MAUDE Adverse Event Report: ABBOTT SRL ALINIQ AMS; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number	03R89-63
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the aliniq ams assigned two patient names to the same id (b)(6) which shows up on one third party analyzer when viewing patient data.There were no incorrect results assigned to a patient.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was provided, no additional patient information was available.
Additional Manufacturer Narrative
The investigation identified an accidental activation of windows defender av (antivirus) scanning on ams folders at the customer site.This caused significant slow processing of hematology sysmex results (>30 seconds for a single sample) causing query timeouts between ams and the analyzer driver.Additionally, the delay was unreported for an extended period.The sysmex driver (xe2100_astm.Dll v5.0.0) was originally designed for older ams versions that required using the ¿last sample id¿ returned from a previous query to populate the order record.Due to the delays, when the first sample arrived at the driver, the stored ¿last sample id¿ corresponded to the second sample, causing the driver to associate incorrect patient information with the arriving sample tube.The processing delays were resolved by disabling the antivirus at the customer site.Ticket trending review did not identify any trends.Device history record review did not identify any non-conformances or potential non-conformances related to the complaint issue.Labeling was reviewed and adequately addressed the issue.Based on the investigation, the aliniq ams software version 3.20 is performing as intended, no systemic issue or deficiency of the aliniq ams software version 3.20 was identified.
Event or Problem Description
The customer reported the aliniq ams assigned two patient names to the same id (b)(6) which shows up on one third party analyzer when viewing patient data.There were no incorrect results assigned to a patient.No impact to patient management was reported.

• Brand Name: ALINIQ AMS
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• Manufacturer (Section G): ABBOTT SRL; via giorgio ribotta 9; rome 00144 ; IT 00144
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24506271
• Report Number: 3004032053-2026-00003
• Device Sequence Number: 9870451
• Product Code: JQP
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2026

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 Catalogue Number: 03R89-63
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/20/2026; 06/25/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/26/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown