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

Catalog Number	03R89-62
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
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.
Event or Problem Description
The customer reported the interpretation for the hbsag assay was incorrectly transferred from the ams sw3.01.The initial result was positive, but the two repeat tests were negative at 052 / 052 s/co but still transferred the positive interpretation from the ams.No impact to patient management was reported.
Event or Problem Description
The customer reported the interpretation for the hbsag assay was incorrectly transferred from the ams sw3.01.The initial result was positive, but the two repeat tests were negative at 052 / 052 s/co but still transferred the positive interpretation from the ams.No impact to patient management was reported.
Additional Manufacturer Narrative
The investigation of an incorrect interpretation of the hbsag assay transferred by the aliniq ams software, version 3.01, concluded that the customer requested the rerun only for the numeric result and not for the qualitative result.This allowed the aliniq ams software to accept the new numeric value but rejected the qualitative result as an invalid rerun.A review of tracking and trending for the aliniq ams software, version 3.01, did not identify an increase in complaint activity related to the complaint issue.The device history record was reviewed and did not identify any non-conformances or potential non-conformances related to the issue described in the current complaint.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency was identified with the aliniq ams software, version 3.01.

• 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: 23787370
• Report Number: 3004032053-2025-00023
• Device Sequence Number: 5521990
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: (01)00380740200169(10)3.01
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 01/26/2026

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: 03R89-62
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/26/2026
• 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