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	07/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed that hbsag results are being reported as negative on the ams when, they are positive.The ams is configured in s/co where the cutoff is >1, while the instrument is releasing the result in iu/ml where the cutoff is >0.05.Therefore, the results are being incorrectly interpreted in ams, since the rule was not configured properly.Since the installation, results between 0.06 and 1 were interpreted as "negative" (b)(6) 2024, sample id (b)(6) result = 0.11.(b)(6) 2024, sample id (b)(6) result = 0.22.(b)(6) 2024, sample id (b)(6) result = 0.10.Sample id (b)(6) result on the instrument = reactive, shown as negative on the ams.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 - patient identifier: sids (b)(6).Section e1- phone number complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, and labeling review.Through the investigation it was determined that results were being wrongly interpreted due to an incorrect measurement unit configured in the ams.The unit and cutoff value were incorrect in the data collection worksheet completed before installation and provided by the engineer during the setup of ams quality programming language (qpl) rules.The issue was corrected by editing the qpl rule according to the customer¿s requirements.An affected sample was rerun, and the correct behavior of the ams was confirmed.No deficiency of the middleware was identified.A review of labeling addresses the issue under review and provides adequate information how to configure rules in the smart rules editor (sre) module of the aliniq ams middleware.A ticket trending report was reviewed and identified no additional complaints related to the current complaint issue.Ticket trending review did not identify any trends for the issue for the product.A device history record review did not identify any non-conformances or potential non-conformances related to the issue under review.Based on the investigation no systemic issue or deficiency with the aliniq ams software (version 3.02) was identified.
Event or Problem Description
The customer observed that hbsag results are being reported as negative on the ams when, they are positive.The ams is configured in s/co where the cutoff is >1, while the instrument is releasing the result in iu/ml where the cutoff is >0.05.Therefore, the results are being incorrectly interpreted in ams, since the rule was not configured properly.Since the installation, results between 0.06 and 1 were interpreted as "negative" (b)(6) 2024 sample id (b)(6) result = 0.11, (b)(6) 2024 sample id (b)(6) result = 0.22, (b)(6) 2024 sample id (b)(6) result = 0.10, sample id (b)(6) result on the instrument = reactive, shown as negative on the 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 20343220
• Report Number: 3004032053-2024-00012
• Device Sequence Number: 20846374
• Product Code: JQP
• UDI-Device Identifier: 00380740202736
• UDI-Public: (01)00380740202736(10)3.02
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/18/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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