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

Catalog Number	03R89-62
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed that ams allowed the order entry module to create a duplicated sid associated to two different requests.After review of logs, it is visible that sample (b)(6) was firstly associated to request 2748860-5583400-114027, but then a duplicate was assigned by order entry to request 1737708-5553733-113594 - no trace of update from lis, only visible in organizer.Results were assigned to other patient with sample identification numbers that were not ordered from his.They were identified and blocked before validation and reporting.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.
Additional Manufacturer Narrative
Complete information for section a1 patient identifier: (b)(6).The investigation by the ams technical experts determined the issue was most likely a case of user error.The exact root cause could not be determined.Communication with the customer revealed that they were trained to follow different steps, using f3 - cancel instead of f5 - clear option in the ams worklist.It is likely that the user accidentally pressed f5 instead of f3.However, this could not be confirmed.The customer was retrained on correct procedures.No deficiency of the middleware was identified.The ticket trending review did not identify an increase in complaint activity.Device history review did not identify any non-conformance's, potential non-conformance's, or deviations associated with the complaint issue.A review of labeling showed labelling to be adequate.Based on all available information and abbott¿s complaint investigation, no product deficiency was identified for the aliniq ams.
Event or Problem Description
The customer observed that ams allowed the order entry module to create a duplicated sid associated to two different requests.After review of logs, it is visible that sample (b)(6) was firstly associated to request (b)(4), but then a duplicate was assigned by order entry to request (b)(4) no trace of update from lis, only visible in organizer.Results were assigned to other patient with sample identification numbers that were not ordered from his.They were identified and blocked before validation and reporting.No impact to patient management was 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: 21253123
• Report Number: 3004032053-2025-00002
• Device Sequence Number: 8075951
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: (01)00380740200169(10)3.01
• Combination Product (Y/N): N
• Initial Reporter Country: BK
• 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): 02/24/2025

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: 03R89-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/24/2025
• 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