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

Catalog Number 03R89-63

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 331368040
• Report Number: 3004032053-2023-00031
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00380740202736
• UDI-Public: (01)00380740202736(10)3.02
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 03R89-63
• Device Lot Number: OCN01128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1