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	09/24/2025
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 an issue with the aliniq ams software base, version 3.02.The customer stated a patient sample with an icteric index of > 711.999 should have triggered the hil indices rule to generate and ict comment in place of the result and hold the result.This was not being performed for the potassium test; therefore, the potassium result with a high icteric index was not being held, and the result was reported out of the lab.The sample id provided was (b)(6); however, no specific test results were provided.There was no impact to patient management reported.
Additional Manufacturer Narrative
Technical investigations performed by the abbott its (informatics technical specialist) revealed that a value of "0" had been inadvertently carried over from an earlier qpl template version, where the parameter was defined as a numeric (float) type.In the updated version, the parameter was redefined as alphanumeric, enabling the field to be left empty (null) instead of requiring a default numeric value.The abbott its recompiled the qpl using the corrected template value.No deficiencies were identified for the middleware.Device history record review revealed that there were no nonconformances or potential nonconformances related to the issue described in the current complaint.A review of the labeling addresses the customer¿s issue.Trending review did not identify any trends.Based on the investigation, no systemic issue or product deficiency was identified for the aliniq ams software version 3.02, list 03r89-63.
Event or Problem Description
The customer reported an issue with the aliniq ams software base, version 3.02.The customer stated a patient sample with an icteric index of > 711.999 should have triggered the hil indices rule to generate and ict comment in place of the result and hold the result.This was not being performed for the potassium test; therefore, the potassium result with a high icteric index was not being held, and the result was reported out of the lab.The sample id provided was (b)(6), however no specific test results were provided.There was 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: 23199558
• Report Number: 3004032053-2025-00018
• Device Sequence Number: 9433356
• 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): 11/17/2025

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: 03R89-63
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/17/2025
• 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: Unknown