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	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.See related manufacturer report 2919069-2025-00053.
Event or Problem Description
The customer reported a falsely decreased hemoglobin result received in the aliniq ams base software for one patient sample.The following events occurred for sample id (b)(6).Original hemoglobin result was received in aliniq ams base software as 65.1 g/l (6.51 g/dl) and the first rerun results for hemoglobin was 149 which displayed in ams.The subsequent four reruns generated results of 149,148, 149 and 148 g/l (14.9, 14.8, 14.9, and 14.8 g/dl) and these results were generated on the analyzer, however, these results did not come across to ams.The rerun results on ams came up as 65 four times.There was no impact to patient management reported.
Event or Problem Description
The customer reported a falsely decreased hemoglobin result received in the aliniq ams base software for one patient sample.The following events occurred for sample id (b)(6): original hemoglobin result was received in aliniq ams base software as 65.1 g/l (6.51 g/dl) and the first rerun results for hemoglobin was 149 which displayed in ams.The subsequent four reruns generated results of 149,148, 149 and 148 g/l (14.9, 14.8, 14.9, and 14.8 g/dl) and these results were generated on the analyzer, however, these results did not come across to ams.The rerun results on ams came up as 65 four times.There was no impact to patient management reported.
Additional Manufacturer Narrative
A review of tracking and trending data for the aliniq ams software (version 3.02) identified no related trends for the current complaint.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling contained adequate information to configure the ams middleware and confirmed it is not related, nor contributing to the issue identified in the current complaint.In this case, the system logs show that sample (b)(6) produced a validated result of 65.1 g/l, and the analyzer¿s configuration correctly blocked rerun results from being accepted for tests that were already closed.Because ams only accepts reruns when a test is manually reopened or triggered by predefined rules, the subsequent rerun values (149, 148, 149, 148) were never sent to ams.Additionally, ams audit logs showed no transmission issues or any user actions to reopen the test for re-runs.All available evidence indicates that the middleware functioned properly at the customer site.Based on the investigation, aliniq ams software (version 3.02) is performing as intended, no systemic issue or product deficiency was identified.See related manufacturer report 2919069-2025-00053.

• 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: 23873139
• Report Number: 3004032053-2025-00024
• Device Sequence Number: 11917020
• Product Code: JQP
• UDI-Device Identifier: 00380740202736
• UDI-Public: (01)00380740202736(10)3.02
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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
• Device Lot Number: OCN02295-801-00
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/11/2026
• 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