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

Model Number	03R89-48
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed mixed results between two aliniq ams test codes.The issue occurred while the customer was implementing and testing a new rule for interpreting results.The rule was intended for assays that require retests in which the final interpretation is only sent after the initial and two additional retests were completed.While testing of the rule patient tubes were placed on the track, measured and the results were reported.It was subsequently discovered that the results were mixed up between two ams test codes.A look back was completed and sample id (b)(6) anti-hbc results were impacted by the error.The interpretation (pos/neg) was correct however for each sample one of the values was havab igg.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.Patient identified: multiple: (b)(6).Patient information: no further patient information was provided.
Additional Manufacturer Narrative
The abbott specialist determined the mixed results between two aliniq ams test codes and related incorrect results released by the middleware to lis was due to a combination of multiple factors: rule requirements agreed and confirmed by the customer were misinterpreted by the abbott customization specialist and such they were wrongly implemented in the rule code (the rule logic was considering only one test result to be managed instead of multiple ones.) rule testing was not properly performed and documented by the abbott customization specialist before the installation and activation in the customer environment.A complete verification of the rule could have detected the incorrect rule behavior in case of multiple tests have been configured in the template.Lab technicians performed incorrect sample management during the test and validation phase of the aliniq ams rule: real patient tubes were placed on the track, measured and incorrect results were reported to the lis.Testing should be performed in a protected environment not using real patient samples.This scenario was addressed through a combination of actions within the middleware: aliniq ams configurator was configured in order to receive and store measurement and interpretation results in dedicated fields of the same test code instead of using two separate test codes for each serology assay; two (custom) rules were created for serology test results evaluation.These new rules use the qplinfo field to copy the first measurement.This field is replicated for each individual test of the sample avoiding the risk of mixing results between different tests.Each configured test uses its own qplinfo field to copy the corresponding first measurement instead of the qplnote field, which is unique for all tests of the sample.Customer validated the new aliniq ams settings and confirmed that the system was working as expected and corrections performed met their needs and expectations.A review of tracking and trending of the aliniq found no additional complaints related to the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation no systemic issue or deficiency with the aliniq ams was identified.

• 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: 15914430
• Report Number: 3004032053-2022-00011
• Device Sequence Number: 20473980
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/13/2023

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: 03R89-48
• Device Catalogue Number: 03R89-48
• 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: 11/25/2022
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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