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

Catalog Number	03R89-63
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed neutrophil results going across to aliniq ams as a percentage, not as a count.The customer stated that the neutrophil results as a percentage, and not a count, didn¿t allow for the customer to determine if results were high or abnormal for patients.There were three sample ids provided (b)(6); however, no patient results were provided.It was noted that the issue was caused by the ¿send to lis after validation¿ button being selected on the ams configurator by the abbott technical support specialist.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for neutrophil results going across to aliniq ams as a percentage, not as a count 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.The investigation revealed that while troubleshooting a neut result upload issue, the 'send to lis after validation' option was inadvertently enabled by the abbott technical service specialist (tss) to match other test configurations.However, the lis had applied internal rules that unintentionally converted absolute values to percentages.As the checkbox was enabled, validated results were automatically sent to the winpath (lis), which was not the intended workflow.The issue was resolved by disabling the option, instructing the customer to delete the affected results, and resending correct data from the ams.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency of aliniq ams software, version 3.02, was identified.
Event or Problem Description
The customer observed neutrophil results going across to aliniq ams as a percentage, not as a count.The customer stated that the neutrophil results as a percentage, and not a count, didn¿t allow for the customer to determine if results were high or abnormal for patients.There were three sample ids provided (b)(4); however, no patient results were provided.It was noted that the issue was caused by the ¿send to lis after validation¿ button being selected on the ams configurator by the abbott technical support specialist.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: 22162299
• Report Number: 3004032053-2025-00015
• Device Sequence Number: 7422076
• 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): 06/25/2025

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: 05/16/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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