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

Model Number	03R89-21
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed incorrect results were being reported by the aliniq ams base software.The aliniq ams reported the results from the genexpert as negative and not detected instead of fail.When the genexpert analyzer is unable to produce a definitive positive or negative result, it generated an error as ¿error¿ and the rule in the ams should have resulted the test as ¿fail¿ if ¿error¿ is present.It was noted that there were multiple rules setup for the same test and the initial result was set to ¿fail¿, however, subsequent rules changed its value and the final result was set at nde (not detected).The customer caught the issue right away and the clinicians were notified.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
Technical investigations on the existing rule settings were performed by the abbott specialist.It was found that there were multiple rules setup in aliniq ams for the same test and the initial result was set to ¿fail¿, however, subsequent rules changed its value, and the final result was set at nde (not detected).Human error during the configuration the aliniq ams interface with the non-abbott (genexpert) instrument and its verification has been confirmed as the root cause of the incorrect test results released by aliniq ams.Specific conditions which required for complete verification of the aliniq ams configuration correctness were not considered by the abbott informatics technical specialist during the rule verification which leaded to the issue described in the complaint.To address this scenario a configuration change was performed by the abbott engineer within the set of aliniq ams rules on january 31, 2023: if a test has result of ¿fail¿, it is validated the tests so that any subsequent rules won't trigger overwriting its value based on other criteria as requested by the customer.The customer caught the issue right away and the clinicians were notified.The interface was switched off until issue is resolved.Based on customer communication during the meetings, 50 (out of 150) wrong results were sent to lis because of the aliniq ams configuration issue, but no patients were impacted by the issue.Ticket trending was reviewed and identified no additional complaints similar to the issue described in the current complaint.The device history record was reviewed and did not identify any non-conformances or potential non-conformances related to the issue described in the current complaint.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency of the aliniq ams middleware was identified.
Event or Problem Description
The customer observed incorrect results were being reported by the aliniq ams base software.The aliniq ams reported the results from the genexpert as negative and not detected instead of fail.When the genexpert analyzer is unable to produce a definitive positive or negative result, it generated an error as ¿error¿ and the rule in the ams should have resulted the test as ¿fail¿ if ¿error¿ is present.It was noted that there were multiple rules setup for the same test and the initial result was set to ¿fail¿, however, subsequent rules changed its value and the final result was set at nde (not detected).The customer caught the issue right away and the clinicians were notified.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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16427077
• Report Number: 3004032053-2023-00006
• Device Sequence Number: 2557115
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: 00380740158255
• 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): 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): 07/14/2023

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: 03R89-21
• Device Catalogue Number: 03R89-21
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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