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

Model 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	01/10/2023
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.
Event or Problem Description
The customer reported a patient processed on (b)(6) 2023 with sid(b)(6) had details from a different patient in the ams.The correct patient details were in the lis that matched the sid therefore the results were reported correctly.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation indicated that the root cause of the issue was a use error in sample management performed by the customer that resulted in an incorrect assignment of the demographic details of a patient to another one in aliniq ams.A barcoded sid label was re-used in the laboratory before a 7-days¿ time frame period configured in aliniq ams.As a consequence of this action, the aliniq ams associated the results received for the instrument to patient id (b)(6), which was still present in the middleware database and linked to this sid (b)(6).Conversely, the lis associated and released the results received from aliniq ams to patient id (b)(6), also associated to sid (b)(6).Since the correct patient details were in the lis that matched the sid, the results were reported correctly.Given that no incorrect behavior was identified in aliniq ams and the correct patient details and results were eventually reported correctly in the lis, no corrections have been taken.No re-occurrence of the events have occurred.Trending review determined no trends for the issue for the product.Device history record review did not show any potential non-conformances, a review of the product labeling concluded that the issue is sufficiently addressed.Based on all available information and abbott diagnostics' complaint investigation, no product deficiency was identified with the aliniiq software.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16285085
• Report Number: 3004032053-2023-00004
• Device Sequence Number: 5020033
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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): 03/17/2023

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 Model Number: 03R89-48
• Device Catalogue Number: 03R89-48
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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