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	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a rule in aliniq ams was not correct.The customer reported that a when a glucose generated error 1039 or 1040, a 1:5 dilution should occur.Sample id (b)(6) generated an elevated glucose result and this rule did not work for sample id (b)(6) in which it should have repeated the test with a 1:5 dilution.Upon further review, the ams was set-up with a standard configuration by abbott personnel.The rule for glucose when the instrument generates error/flag 1039 or 1040 to rerun with 1:5 dilution was set correctly, however a subsequent rerun rule for the same error/flag to repeat with a dilution of 1 was over-ridding the glucose rule.It was reported that the sequential order of the rules have now been re-ordered.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The aliniq ams sw 3.02 was evaluated.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search and trending did not find an increase in complaint activity related to the customer reported issue.Device history review did not identify any issues.Labeling was reviewed and was found to address the customer reported issue.The investigation found that the configuration was not set-up correctly.The rule for glucose when the instrument generates error/flag 1039 or 1040 to rerun with 1:5 dilution was set correctly, however a subsequent rerun rule for the same error/flag to repeat with a dilution of 1 was over-ridding the 1:5 dilution rule.The rule order was corrected and activated at the customer site.Based on the investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer reported that a rule in aliniq ams was not correct.The customer reported that a when a glucose generated error 1039 or 1040, a 1:5 dilution should occur.Sample id: (b)(6) generated an elevated glucose result and this rule did not work for sample id: (b)(6) in which it should have repeated the test with a 1:5 dilution.Upon further review, the ams was set-up with a standard configuration by abbott personnel.The rule for glucose when the instrument generates error/flag 1039 or 1040 to rerun with 1:5 dilution was set correctly, however a subsequent rerun rule for the same error/flag to repeat with a dilution of 1 was over-ridding the glucose rule.It was reported that the sequential order of the rules have now been re-ordered.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: 21819176
• Report Number: 3004032053-2025-00010
• Device Sequence Number: 21018237
• 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): 05/15/2025

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
• Device Lot Number: V3.02
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/15/2025
• 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