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

Catalog Number	03R89-21
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2024
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.
Event or Problem Description
The customer reported that after a new rule was implemented in the aliniq ams, that results generated for urinary proteins and glycosuria were incorrect.The new rule was to have a conversion factor for the results to match a change in the unit of measure from mg/dl to g/l for.The customer further elaborated that the incorrect results were because the conversion factor did not occur.The customer reported that they corrected the incorrect results that were generated on (b)(6) 2023, which impacted 37 patients.Upon further review, the rule placed in aliniq ams to convert the unit of measure from mg/dl to g/l was placed after an established rule.This established rule takes the results from the alinity analyzer and places them into the customer¿s laboratory information system (lis).Since this established rule was positioned before the new conversion rule, the established rule was triggered first.Therefore, the conversion factor did not occur before the results entered the customer¿s lis.The sequence of the rules has been changed so that the conversion rule occurs first.The customer confirmed that the results now have the correct value and unit of measure.There was no reported impact to patient management.
Additional Manufacturer Narrative
A complaint investigation was conducted and after review of the available information there was no deficiency of the device identified.There was no risk for death or serious deterioration in state of health identified for the event, therefore this event is no longer reportable.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.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 unexpected behavior was due to an interference between an established rule and a conversion rule due to their order/sequence.To note, the established rule was a rule that takes the results from the alinity analyzer and placed them into the customer¿s laboratory information system (lis).Upon further review, since this established rule was positioned before the new conversion rule, the established rule was triggered first.Therefore, the conversion factor did not occur before the results were placed in the customer¿s lis.The rule was validated and this issue was not discovered at that time.Once the sequence of the rules were changed so that the rule for conversion triggered before the established rule, the customer confirmed the results have the correct value and unit of measure.Based on the available information within the complaint, the aliniq ams behaved as per the configurations set at the customer site.Based on the investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer reported that after a new rule was implemented in the aliniq ams, that results generated for urinary proteins and glycosuria were incorrect.The new rule was to have a conversion factor for the results to match a change in the unit of measure from mg/dl to g/l for.The customer further elaborated that the incorrect results were because the conversion factor did not occur.The customer reported that they corrected the incorrect results that were generated on (b)(6) 2023, which impacted 37 patients.Upon further review, the rule placed in aliniq ams to convert the unit of measure from mg/dl to g/l was placed after an established rule.This established rule takes the results from the alinity analyzer and places them into the customer¿s laboratory information system (lis).Since this established rule was positioned before the new conversion rule, the established rule was triggered first.Therefore, the conversion factor did not occur before the results entered the customer¿s lis.The sequence of the rules has been changed so that the conversion rule occurs first.The customer confirmed that the results now have the correct value and unit of measure.There was no reported impact to patient management.

• 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: 18669281
• Report Number: 3004032053-2024-00001
• Device Sequence Number: 20662066
• Product Code: JQP
• UDI-Device Identifier: 00380740158255
• UDI-Public: 00380740158255
• 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): 03/12/2024

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: 03R89-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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