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

Catalog Number	03R89-24
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2025
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.Section a1: patient identifier complete entry sid: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a result mismatch for two patient samples by the alinity ci-series system control module and the aliniq ams software.The customer reported that an incorrect microalbumin result for sid: (b)(6) was released by the alinity ci-series system control module into the aliniq ams software for a patient.On (b)(6) 2025, sid: (b)(6) generated a microalbumin result of <5.0 mg/l, which was released into the aliniq ams software.The next sample, sample id: (b)(6), generated a microalbumin result of 28.5 mg/l, which was released into the aliniq ams software under sid: (b)(6).Consequently, the microalbumin result for sid: (b)(6) was reported out of the lab as 28.5 mg/l (incorrect result) instead of <5.0 mg/l (correct result).The customer has since amended the patient report.The abbott service team was unable to determine if the issue was caused by the aliniq ams software or the alinity ci-series system control module, so this incident will be reported under both products.There was no impact to patient management reported.
Additional Manufacturer Narrative
Fields d3 email and g1 mfg site email updated.The complaint investigation for mismatch in microalbumin test results on the aliniq ams software included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.Log analysis and investigation by the ams technical experts confirmed the occurrence and indicated a potential issue in the transmission of results from the alinity analyzer.This subsequently led to incorrect reporting by the ams.However, this could not be confirmed, as the ssd drive on alinity scm was not available for further investigation.The abbott personnel restored the alinity_ci.Dll driver (4.0.3.0) to its previous version, which resolved the issue.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency of aliniq ams software, version 2.10, was identified.
Event or Problem Description
The customer observed a result mismatch for two patient samples by the alinity ci-series system control module and the aliniq ams software.The customer reported that an incorrect microalbumin result for sid (b)(6) was released by the alinity ci-series system control module into the aliniq ams software for a patient.On (b)(6) 2025, sid (b)(6) generated a microalbumin result of <5.0 mg/l, which was released into the aliniq ams software.The next sample, sample id (b)(6), generated a microalbumin result of 28.5 mg/l, which was released into the aliniq ams software under sid (b)(6).Consequently, the microalbumin result for sid (b)(6) was reported out of the lab as 28.5 mg/l (incorrect result) instead of <5.0 mg/l (correct result).The customer has since amended the patient report.The abbott service team was unable to determine if the issue was caused by the aliniq ams software or the alinity ci-series system control module, so this incident will be reported under both products.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: 21294803
• Report Number: 3004032053-2025-00003
• Device Sequence Number: 18473611
• Product Code: JQP
• UDI-Device Identifier: 00380740145125
• UDI-Public: (01)00380740145125(10)2.10
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 03/19/2025

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: 03R89-24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/19/2025
• 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