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

Catalog Number 03R89-62

Device Problem Computer Software Problem (1112)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

On (b)(6) 2023, the customer provided a sample id (b)(6) that was said to have incorrect data populated in the aliniq ams base software regarding a alinity i total b-hcg test result.The following data was provided: 1st result was primary = 964.20 miu/ml; secondary result transmitted from instrument = positive 2nd result after running the automatic dilution, primary result < 7000 miu/ml; secondary result transmitted from instrument = positive however, ams read primary result < 7000 and flag <, for which exists a rule that generates the result as absent.It was noted that the aliniq ams base software was incorrectly configured for the alinity i total b-hcg result.It was noted that the dilution was automatically triggered by the ams due to an incorrect rule configuration.There was no impact to patient management reported.

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, device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of ticket trending did not identify any related trends for the current complaint issue.A review of the device history record did not identify any non-conformances or deviations related to the complaint issue.Labeling was reviewed and adequately addresses the issue under review.In this case, the issue was identified as an incorrect configuration of the qpl (quality programming language) rules on the aliniq ams software version 3.01 (ln 03r89-62) for the alinity i total b-hcg assay.Based on the investigation, the aliniq ams software version 3.01 (ln 03r89-62) is performing as intended, no systemic issue or product deficiency was identified.

Event Description

On 08dec2023, the customer provided a sample id (b)(6) that was said to have incorrect data populated in the aliniq ams base software regarding a alinity i total b-hcg test result.The following data was provided: 1st result was primary = 964.20 miu/ml; secondary result transmitted from instrument = positive.2nd result after running the automatic dilution, primary result < 7000 miu/ml; secondary result transmitted from instrument = positive.However, ams read primary result < 7000 and flag <, for which exists a rule that generates the result as absent.It was noted that the aliniq ams base software was incorrectly configured for the alinity i total b-hcg result.It was noted that the dilution was automatically triggered by the ams due to an incorrect rule configuration.There was no impact to patient management reported.

• 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: 18363824
• MDR Text Key: 331308815
• Report Number: 3004032053-2023-00029
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: 00380740200169
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03R89-62
• Device Lot Number: OCN03337
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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