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

Catalog Number	03R89-62
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer stated that enterovirus (entp) results released from their elite analyzer are shown under adenovirus (adep) in the aliniq ams (analyzer management system).The customer stated that results for 92 samples have been release since going live on (b)(6), 2023.Of this, 14 results were positive for mv or mv2.Of this, 3 were identified as positive for mv2.Of this, 2 had results that were authorized and released.The results were questioned and the clinical teams have been contacted and patients discussed.Review of the result logs identified that the analyzer result string order needed to be updated.The correction was made and results are now being acquired in the correct order and matching expectations.No impact to patient management was reported.
Additional Manufacturer Narrative
Technical investigations performed by the abbott specialist confirmed that the issue was caused by a human error performed by the abbott informatic technical specialist during the aliniq ams custom rule (qlib_cst_ade_ingenius_bsps) configuration and verification that led to a release of incorrect results by aliniq ams: enterovirus (entp) result delivered by the instrument was assigned to adenovirus (adep) result.Adenovirus (adep) result delivered by the instrument was assigned to enterovirus (entp) result.The sre result log files analysis reported that original rule requirements were respected but a specific scenario wasn¿t tested: the sample used during rule verification had equal values of enterovirus (entp) and adenovirus (adep) therefore the error was not detected by the abbott informatic technical specialist.Review of the sre result logs identified that the analyzer results order needed to be updated in the aliniq ams rule to correct discrepancies of results.The correction was made by the local abbott informatic technical specialist through a configuration change within the aliniq ams rule at the customer site: the custom rule qlib_cst_ade_ingenius_bsps was modified in order to align the results order of the impacted tests (ent 1st, pae 2nd and ade 3rd) and requested re-test and to correctly save the enterovirus and adenovirus results in aliniq ams.The rule was successfully verified after modification implementation.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.All information required for rule creation and modification is described in the aliniq ams 3.01 smart rules editor (sre) user manual, rev.0.Trending review determined no trend for the issue for the product.Based on the investigation, no product deficiencies were identified.
Event or Problem Description
The customer stated that enterovirus (entp) results released from their elite analyzer are shown under adenovirus (adep) in the aliniq ams (analyzer management system).The customer stated that results for 92 samples have been release since going live on (b)(6) 2023.Of this, 14 results were positive for mv or mv2.Of this, 3 were identified as positive for mv2.Of this, 2 had results that were authorized and released.The results were questioned and the clinical teams have been contacted and patients discussed.Review of the result logs identified that the analyzer result string order needed to be updated.The correction was made and results are now being acquired in the correct order and matching expectations.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: 17577151
• Report Number: 3004032053-2023-00021
• Device Sequence Number: 15540963
• Product Code: JQP
• UDI-Device Identifier: 00380740200169
• UDI-Public: 00380740200169
• 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): 09/21/2023

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 Catalogue Number: 03R89-62
• Device Lot Number: OCN03439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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