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

Catalog Number	03R89-62
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed that the aliniq ams transmitted a different patient name to the analyzer compared to the barcode on the sample.The customer confirmed that the patient name in the lis matched the patient's name on the barcode.This occurred while two samples (sids (b)(6), were run at the same time.No impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 - patient identifier: sids (b)(6).All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The investigation identified that the issue stemmed from an incomplete order entry in the customer¿s laboratory information system (lis).The first order (sid (b)(6) was never fully completed before the second order (sid (b)(6) was created.When the lis transmitted sid (b)(6), it ended the message with an , causing the ams host driver to expect additional data.Instead, the lis sent a new patient record.Due to the incomplete order entry and the message termination, the ams system carried over the demographics from the first sid to the second.A review of tracking and trending of the aliniq did not identify any trends related to the complaint issue.A review of manufacturing documentation did not identify any issues associated with the complaint issue.A review of the labeling indicated it is not related, nor contributing to the issue identified in the current complaint.Based on the investigation the aliniq ams is performing as intended, no systemic issue or deficiency of the aliniq ams, software (version 3.01) was identified.
Event or Problem Description
The customer observed that the aliniq ams transmitted a different patient name to the analyzer compared to the barcode on the sample.The customer confirmed that the patient's name in the lis matched the patient's name on the barcode.This occurred while two samples (sids (b)(6), were run at the same time.No impact to patient management 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: 23437511
• Report Number: 3004032053-2025-00022
• Device Sequence Number: 17301343
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: (01)00380740200169(10)3.01
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 01/05/2026

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
• Device Lot Number: OCN03777-801
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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