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

Catalog Number	03R89-63
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported incorrect aliniq ams software version 3.01 configuration and provided the following information: customer stated that there have been occasions where elements of sigma strong assays have not been completed correctly.More specifically, the impacted sigma strong assays have not been implemented with linear ranges.The customer reported that this has been associated with several incidents linked to patient samples being reported late and/or incorrectly, however the was no reported impact to patient management.The customer reported that abbott personnel performed the aliniq ams configuration implementation and that the assay performance with the instrument is within expectations based on verification.There was no reported impact to patient management.
Event or Problem Description
The customer reported incorrect aliniq ams software version 3.01 configuration and provided the following information: customer stated that there have been occasions where elements of sigma strong assays have not been completed correctly.More specifically, the impacted sigma strong assays have not been implemented with linear ranges.The customer reported that this has been associated with several incidents linked to patient samples being reported late and/or incorrectly, however the was no reported impact to patient management.The customer reported that abbott personnel performed the aliniq ams configuration implementation and that the assay performance with the instrument is within expectations based on verification.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search and trending did not find any additional complaints similar to the customer reported issue.Device history review did not identify any nonconformances or potential nonconformances related to the customer reported issue.Labeling was reviewed and was found to address the customer reported issue.The customer reported assays were not completed correctly in aliniq ams.The investigation found that partial information was provided and confirmed the reported issue was a result of assays not being configured correctly in aliniq ams.The customer was provided with a checklist of the parameters to be reviewed for implementation into aliniq ams.Based on the available information within the complaint, the aliniq ams contained an incorrect configuration.Based on the investigation, no systemic issue or deficiency 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: 18377640
• Report Number: 3004032053-2023-00031
• Device Sequence Number: 7711030
• Product Code: JQP
• UDI-Device Identifier: 00380740202736
• UDI-Public: (01)00380740202736(10)3.02
• 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): 04/16/2024

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
• Device Lot Number: OCN01128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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