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	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete sample id is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported that the resutls in aliniq ams didn't match the results from the analyzer for sample id (b)(6), which is from an 82-year-old female patient.The customer reported that the sample was run on analyzer (name: fpcac4).When the customer looked at the results in ams, the customer noted that the results were not the same.The customer also noted that ams displayed that the patient sample was run on another analyzer (name: fpcac5), however the sample actually run on analyzer (name: fpcac4).The customer went to the analyzer (name: fpcac4) and printed out the sample results, which were the correct results.The customer confirmed that ams did not release any incorrect results.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 customer reported a mismatch between results displayed in aliniq ams and those printed from analyzer (b)(6) for sample id (b)(6).Although the sample was run on (b)(6), ams showed results from analyzer (b)(6).The investigation confirmed that (b)(6) results were correctly transmitted to ams.The report logs verified that the aliniq ams received only vitamin b12 results from (b)(6), which was correctly run on (b)(6).The sample was tested on both analyzers for different assays, and all results received were accurate.No data mismatches or deficiencies in aliniq ams software (v3.02) were found.A review of tracking and trending of the aliniq found no additional complaints replated to the complaint issue.Therefore, no trends were identified.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of the labeling addresses the customer¿s issue and confirmed that labelling 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 3.02) was identified.
Event or Problem Description
The customer reported that the results in aliniq ams didn't match the results from the analyzer for sample id (b)(6), which is from an 82-year-old female patient.The customer reported that the sample was run on analyzer (name: (b)(6)).When the customer looked at the results in ams, the customer noted that the results were not the same.The customer also noted that ams displayed that the patient sample was run on another analyzer (name: (b)(6)), however the sample actually run on analyzer (name: (b)(6)).The customer went to the analyzer (name: fpcac4) and printed out the sample results, which were the correct results.The customer confirmed that ams did not release any incorrect results.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.

• 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: 23256344
• Report Number: 3004032053-2025-00020
• Device Sequence Number: 18684041
• 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): 11/14/2025

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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 11/14/2025
• 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 Age: 82 YR
• Patient Sex: Female