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

Catalog 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	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 patient identifier: complete list of sample id's are (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
Incorrect results were generated after a rule was implemented in aliniq ams.The following information was provided: the customer reported that the current aliniq ams rule only performs a conversion on numerical results, so it doesn¿t work on < 25 results for alpha-1-anti-trypsin results.The customer requested a new rule so that instead of low the result of <25 would be numerical / quantitative.The customer contacted abbott for a newly requested rule.The new rule was activated and testing of the new rule was planned.In the process to have the new rule tested, two samples generated incorrect results.Sample id (b)(6) ams reported alpha 1 antitrypsin result was < 0.25, real value was 1.22.Sample id (b)(6) ams reported alpha 1 antitrypsin result was < 0.25, real value was 1.61.Upon review, the results went through existing rules in aliniq ams in addition to this new rule that was activated, which led to the incorrect result outcome.Aliniq ams sent the incorrect results to the lis, however the customer corrected the results in lis before official reports were given to patient.The aliniq ams rules have been modified, tested, and everything is now working ok.The customer reported that the incorrect results were corrected before they were given to the patients.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review, and in-house testing.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search and trending did not find any additional complaints similar to the customer reported issue.Device history review did not identify any nonconformances or potential nonconformances.Labeling was reviewed and was found to address the customer reported issue.The investigation found that the results passed through an existing rule in addition to the new rule requested by the customer.The new rule was corrected, and correct functionality of the rule was then verified at the customer site.Based on the investigation, no systemic issue or deficiency was identified for the aliniq ams.
Event or Problem Description
Incorrect results were generated after a rule was implemented in aliniq ams.The following information was provided: the customer reported that the current aliniq ams rule only performs a conversion on numerical results, so it doesn¿t work on < 25 results for alpha-1-anti-trypsin results.The customer requested a new rule so that instead of low the result of <25 would be numerical / quantitative.The customer contacted abbott for a newly requested rule.The new rule was activated and testing of the new rule was planned.In the process to have the new rule tested, two samples generated incorrect results.Sample id (b)(6) ams reported alpha 1 antitrypsin result was < 0.25, real value was 1.22.Sample id (b)(6) ams reported alpha 1 antitrypsin result was < 0.25, real value was 1.61.Upon review, the results went through existing rules in aliniq ams in addition to this new rule that was activated, which led to the incorrect result outcome.Aliniq ams sent the incorrect results to the lis, however the customer corrected the results in lis before official reports were given to patient.The aliniq ams rules have been modified, tested, and everything is now working ok.The customer reported that the incorrect results were corrected before they were given to the patients.There was no impact to patient management 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: 19553744
• Report Number: 3004032053-2024-00004
• Device Sequence Number: 6715898
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: (01)00380740189914(10)2.12
• 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): 07/25/2024

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: 03R89-48
• Device Lot Number: OCE00879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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