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

Catalog Number	03R89-62
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.
Event or Problem Description
This event is considered a use error.The customer stated that a 52-year-old female patient received an unnecessary blood transfusion after the lab technician manually validated a result that was flagged invalid and was blocked by the aliniq ams correctly.The patient results for sid (b)(6) were sent by the customer¿s hematology platform (sysmex xn1000) to the ams on (b)(6) 2025 at 7:51 a.M.The ams functioned correctly and blocked the result due to an invalid data flag for basophils, eosinophils, lymphocytes and monocytes.The use error occurred as the lab technician incorrectly manually unblocked the results and manually validated the results.The patient received a blood transfusion based on the results that were manually validated and released by the lab technician (customer not willing to provide any result details or further information).The customer confirmed that the patient is doing okay and did not have any adverse reaction to the blood transfusion.
Event or Problem Description
This event is considered a use error.The customer stated that a 52-year-old female patient received an unnecessary blood transfusion after the lab technician manually validated a result that was flagged invalid (***) and was blocked by the aliniq ams correctly.The patient results for sid (b)(6) were sent by the customer¿s hematology platform (sysmex xn1000) to the ams on (b)(6) 2025 at 7:51 a.M.The ams functioned correctly and blocked the result due to an invalid data flag (***) for basophils, eosinophils, lymphocytes and monocytes.The use error occurred as the lab technician incorrectly manually unblocked the results and manually validated the results.The patient received a blood transfusion based on the results that were manually validated and released by the lab technician (customer not willing to provide any result details or further information).The customer confirmed that the patient is doing okay and did not have any adverse reaction to the blood transfusion.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The investigation confirmed the results for sid (b)(6) were correctly flagged as ¿***¿ due to invalid data (¿---¿) and blocked by the aliniq ams middleware.System events from the date of the incident clearly indicated that new results were entered for the sample which was unblocked, values manually validated and sent to the lis.The customer's internal investigation acknowledged the action of sending the results to the lis was an operational error and not abbott's responsibility.They requested visual enhancements to improve the visibility of flags in aliniq ams in the future.No malfunctions or deficiencies were identified.Review of tracking and trending did not identify an increase in complaint activity related to the complaint issue.Labeling was reviewed which adequately addresses the current issue.Based on the available information within the complaint record, the aliniq ams software met performance specifications and behaved as per its intended design at the customer site.

• 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: 22331161
• Report Number: 3004032053-2025-00017
• Device Sequence Number: 8300600
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: (01)00380740200169
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/21/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03R89-62
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female