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

Catalog Number	03R89-65
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
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.A1 patient identifier: complete list of id's are (b)(6).
Event or Problem Description
The customer reported that aliniq ams was involved with an event in which patients' results were integrated to another patient's results.The following samples involved tsh and vitamin d: results from id (b)(6) were transmitted to id (b)(6) results were transmitted to id (b)(6).The customer also reported that id (b)(60 as being related to this event.The patients are female.The following involved potassium: potassium results of 4.2941mmol/l from id (b)(6) were transmitted to id (b)(6), with a result of 2.6105 mmol/l.The results were in the customer's laboratory information system and was not reported out to the patient healthcare provider.During this the patient result event, the computer that was hosting the aliniq ams crashed and lost connection.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Event or Problem Description
The customer reported that aliniq ams was involved with an event in which patients' results were integrated to another patient's results.The following samples involved tsh and vitamin d: results from id (b)(6), were transmitted to id (b)(6), and id (b)(6), results were transmitted to id (b)(6).The customer also reported that id (b)(6), as being related to this event.The patients are female.The following involved potassium: potassium results of 4.2941mmol/l from id (b)(6), were transmitted to id (b)(6), with a result of 2.6105 mmol/l.The resutls were in the customer's laboratory information system and was not reported out to the patient healthcare provider.During this the patient result event, the computer that was hosting the aliniq ams crashed and lost connection.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The investigation concluded that the result processing delays on the workstation prevented the driver from polling the communication line effectively, causing incoming messages to be missed in real time, leading to a misinterpretation that multiple messages were being sent simultaneously.The customer¿s current driver version could not handle multiple messages in a single package and incorrectly assigned the second result to the first sample.To resolve the issue, the customer replaced the workstation, and the driver was updated, which properly manages multiple message structures.A review of tracking and trending for the aliniq ams software 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 3.03.

• 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: 23310860
• Report Number: 3004032053-2025-00021
• Device Sequence Number: 5789202
• Product Code: JQP
• UDI-Device Identifier: 00380740202736
• UDI-Public: (01)00380740202736(10)3.03
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/30/2025

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: 03R89-65
• Device Lot Number: 3.03
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/30/2025
• 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: Female