MAUDE Adverse Event Report: Abbott Srl AlinIQ AMS; Calculator/data processing module, for clinical use

Catalog Number	03R89-48
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed mismatched results and communication timed out errors on the aliniq ams.The customer stated sid (b)(6) (35-year-old female) results (2.55/reactive) were mismatched with sid (b)(6) (42-year-old female) for havab ig results (0.26/nonreactive).The customer stated results were not reported outside of the lab and were processed on the alinity i processing modules.After ams los driver was upgraded from v4.4.0.0 to v4.4.4.0, no further issues were observed.No impact to patient management was reported.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.

• 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 ; +49()6122582960
• MDR Report Key: 50484394
• Report Number: 3004032053-2026-00006
• Device Sequence Number: 10203156
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: (01)00380740189914(10)2.12
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/27/2026

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: 03R89-48
• Device Lot Number: OCN02660-801
• 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: 08/20/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 35 YR
• Patient Sex: Unknown