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

Model Number	03R89-62
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 observed an instrument error code instead of a numerical value while running the urinary benzodiazepine assay and the error code was interpreted by aliniq ams as a ¿negative¿ result.This occurred after upgrading to version 3.01 of ams.No impact to patient management was reported.
Additional Manufacturer Narrative
Technical investigations performed by the abbott specialist revealed that aliniq ams received the urinary benzodiazepines alphanumerical results ¿![error code]¿ when the alinity ci is not able to provide a numeric result.The error message result triggered an aliniq ams custom rule that change the result in ¿negative¿.In this specific case, since the aliniq ams rule didn¿t have any check on the type of the result, despite an alphanumerical result was received, the rule was triggered and executed, providing incorrect outcome.It happened because the alphanumerical value ¿! [error code]¿ is converted in result =-888888 and getvaluetype is flag set to ¿alpha¿ as per the aliniq ams¿ smart rule editor module (sre) behavior.To address this scenario, the aliniq ams rule was changed so that a control is performed to stop results that are alphanumerical or empty.A retrospective review of the affected patient samples was performed to identify those samples managed between (b)(6) 2020 and (b)(6) 2023.Analysis of the historical data in the aliniq ams database identified 707 samples were impacted by the described wrong behavior of the rule.For all the cases reviewed, 1 sample (sid (b)(6) managed on (b)(6) 2021) with ¿negative¿ result has been manually validated by the laboratory staff without any test repetition and send to the lis.All the other ones have been re-run by the customer, manually validated and sent to the lis.Device history record review revealed that there were no nonconformances or potential nonconformances related to the issue described in the current complaint.A review of the labeling addresses the customer¿s issue.Trending review did not identify any trends.Based on the investigation, no deficiency was identified.
Event or Problem Description
The customer observed an instrument error code instead of a numerical value while running the urinary benzodiazepine assay and the error code was interpreted by aliniq ams as a ¿negative¿ result.This occurred after upgrading to version 3.01 of ams.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: 16496238
• Report Number: 3004032053-2023-00010
• Device Sequence Number: 6610973
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: 00380740200169
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/18/2023

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: 03R89-62
• Device Catalogue Number: 03R89-62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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