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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated postal code (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed that hiv results auto released from aniq ams software that connected to alinity m processing module.The customer has range setup in ams software that hold all hiv results if >50 for manual verification.That range was setup in ams software at the time of installation and that validated by the customer.On 05feb2023 all hiv results started auto released without holding if results >50.The abbott fsr found that samples are partially validated because results are not being copied to the lis hiv dummy test code causing samples to remain on ¿to validate¿ list and test type was changed to textual a day before by abbott remotely.The abbott fsr restarted the services, and the results were copied to the dummy test as samples were closing properly.There is no information regarding any discrepant results reported.No further impact to patient management reported.
Additional Manufacturer Narrative
The abbott specialist performed technical investigations, revealed the issue was a configuration error performed by the abbott specialist that led to a hiv workflow and sample management.A review of 12 months of complaint data did not identify any adverse trends or any non-statistical trends or any atypical complaint activity associated with this described issue.A review of tracking and trending of the aliniq found no additional complaints replated to the complaint issue.Therefore, no trends were identified.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of the labeling addresses the customer¿s issue: aliniq ams configurator user manual en 3.01 rev0 provides adequate information about how to configure the test type in aliniq ams and the validation method in the analyzer section.Based on the information within the complaint, a malfunction was identified: a human (abbott specialist) error in the aliniq ams configuration was the cause of the reported issue which caused a failure in the device to perform as intended at the customer site.No deficiencies were identified in the aliniq ams middleware.

• 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: 16448486
• Report Number: 3004032053-2023-00008
• Device Sequence Number: 12162494
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: 00380740200169
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 05/01/2023

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
• Device Lot Number: OCN03578
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 05/01/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown