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	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed an incorrect result of 99 mmol/mol for a1c reported from their lis, labtrack.The results generated by the tosoh hb were <6 for sid (b)(6).The sample was processed 6 times with results = sa1c <6 mmol/mol or producing a blank result with a flag ¿41¿ which means a low sa1c.The customer was unable to determine where the result of 99 mmol/mol was entered but believes it originated from the ams.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed an incorrect result of 99 mmol/mol for a1c reported from their lis, labtrack.The results generated by the tosoh hb were <6 for sid (b)(6).The sample was processed 6 times with results = sa1c <6 mmol/mol or producing a blank result with a flag ¿41¿ which means a low sa1c.The customer was unable to determine where the result of 99 mmol/mol was entered but believes it originated from the ams.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.The investigation by the abbott its did not find sufficient evidence to suggest that the incorrect result value "99 mmol/mol" was entered by the ams.Additional investigation could not be conducted due to the unavailability of logs from the time of the event, and no updates were provided regarding the customer's internal investigation.Based on the available information, it was determined the aliniq ams software (version 3.02) functioned as expected, with no other occurrences recorded since.The abbott its further confirmed the middleware had been working as expected since installation.A review of the labeling confirmed that it provides sufficient information for configuring the aliniq ams middleware and highlights the customer's responsibility to ensure correct operation.Trending review determined normal complaint activity for the issue for the product.A device history record review did not identify any non-conformances or potential non-conformances related to the issue under review.Based on the investigation no systemic issue or deficiency with the aliniq ams software (version 3.02) was identified.

• 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: 21307362
• Report Number: 3004032053-2025-00004
• Device Sequence Number: 8020285
• 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): 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): 03/13/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/13/2025
• 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