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

Catalog Number	03R89-48
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the aliniq ams assigned a result generated from the alinity to an incorrect patient sample (40 year old female, (b)(6).A urine sample had a drug screen and creatinine tests ordered on it.In the aliniq ams a cocaine result of <0.19 was showing for the sample.However, the cocaine reagent wasn¿t loaded on the instrument.Upon review, the instrument ran a lactate test on an unrequested urine sample, and the result was erroneously linked to the cocaine test on the aliniq ams.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.
Event or Problem Description
The customer reported the aliniq ams assigned a result generated from the alinity to an incorrect patient sample (40-year-old female, sid (b)(6).A urine sample had a drug screen and creatinine tests ordered on it.In the aliniq ams a cocaine result of <0.19 was showing for the sample.However, the cocaine reagent wasn¿t loaded on the instrument.Upon review, the instrument ran a lactate test on an unrequested urine sample, and the result was erroneously linked to the cocaine test on the aliniq ams.No impact to patient management was reported.
Additional Manufacturer Narrative
The issue arose when a customer requested an assay code change.The update was carried out using the instrument configuration interface, which is sorted by channel.During the update, an adjacent channel was unintentionally modified due to the assays having consecutive numbers.This occurred only on that specific alinity instrument and was performed by abbott service personnel.The modification of an extra channel led to incorrect test result mapping and caused the ams to assign a lactate result to a cocaine test field.A database query confirmed that only one sample had been reported with the incorrect assay number on that instrument.To resolve this issue, the assay number was promptly corrected, followed by a service restart to ensure the configuration update was effective.Additionally, the customer was educated on how to verify assay numbers in the configurator to confirm changes after future requests.A review of the labeling addresses the customer¿s issue and confirmed that labelling is not related, nor contributing to the issue identified in the current complaint.A 12-month review of similar complaints did not identify an increase in complaint activity related to the complaint issue.A device history record review did not identify any nonconformances, potential nonconformance or deviations associated with the current complaint issue.Based on the available information no deficiency related to the current complaint issue 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: 23233070
• Report Number: 3004032053-2025-00019
• Device Sequence Number: 18597077
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: (01)00380740189914(10)2.12
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/29/2025

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: 03R89-48
• Device Lot Number: 2.12
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 10/29/2025
• 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 Age: 40 YR
• Patient Sex: Female