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	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a rule on the aliniq ams software version 2.10 was working previously and is now not enabling hil (hemolysis, icterus, lipemia) rules for an alinity c processing module (sn: (b)(6) ) and the customer provided the following data: sample id (b)(6): due to the high level of h, the rule should have removed the pot and ast results, however the results were able to be reported out of the laboratory.The customer also reported a total there was 14 grossly hemolyzed samples over a 12 hr period.All the affected patient samples had to be reran and, in some cases, repeat samples sent to the lab.Upon review, it was determined the instrument module was not configured correctly and was not converted to a user-friendly name and was missing from the family rule, and the module was added to the rule.There has been no known further reported impact to patient management.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.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 a rule on the aliniq ams software version 2.10 was working previously and is now not enabling hil (hemolysis, icterus, lipemia) rules for an alinity c processing module (sn: (b)(6)) and the customer provided the following data: sample id (b)(6): due to the high level of h, the rule should have removed the pot and ast results, however the results were able to be reported out of the laboratory.The customer also reported a total there was 14 grossly hemolyzed samples over a 12hr period.All the affected patient samples had to be reran and, in some cases, repeat samples sent to the lab.Upon review, it was determined the instrument module was not configured correctly and was not converted to a user-friendly name and was missing from the family rule, and the module was added to the rule.There has been no known further reported impact to patient management.
Additional Manufacturer Narrative
H3 was updated to state the investigation is still in process.
Additional Manufacturer Narrative
Section a1 patient identifier: complete list of sample id's are (b)(6).Section b5 was updated with additional information.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 to maintain performance, the customer has a restart of the analyzer service automatically scheduled daily at 4:00 am.The analyzer service manages the communication involved with the instrument (i.E.Alinity ci instrument).It was observed that, on (b)(6) 2023 the service restart was completed but the complete aliniq ams rules were not loaded for use by the analyzer service.This led to the hil (hemolysis, icterus, lipemia) indices rule to not trigger correctly.Upon further review, the issue no longer occurred after the next daily restart, in which the aliniq ams rules were correctly loaded.Restart of the analyzer service and aliniq ams functions were monitored for several days after this event, but no reoccurrences were observed by abbott and none were reported by the customer.All the configured aliniq ams rules were reviewed and no other unexpected behavior were identified.Testing was performed in an internal abbott environment to investigate the reported issue, but testing did not replicate the scenario that after stopping and then restarting the analyzer service, the aliniq ams rules was not loaded.Based on the investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer reported that a rule on the aliniq ams software version 2.10 was working previously and is now not enabling hil (hemolysis, icterus, lipemia) rules for an alinity c processing module (sn: (b)(6)) and the customer provided the following data: sample id (b)(6): due to the high level of h, the rule should have removed the pot and ast results, however the results were able to be reported out of the laboratory.The customer also reported a total there was 14 grossly hemolyzed samples over a 12hr period.All the affected patient samples had to be reran and, in some cases, repeat samples sent to the lab.Upon review, it was determined the instrument module was not configured correctly and was not converted to a user-friendly name and was missing from the family rule, and the module was added to the rule.There has been no known further reported impact to patient management.Update: additional information received on 2 jan 2023; the samples id's that required amendments were (b)(6).Aliniq ams software version 2.12, not 2.10.

• 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: 17561567
• Report Number: 3004032053-2023-00020
• Device Sequence Number: 17806836
• Product Code: JQP
• UDI-Device Identifier: 00380740189914
• UDI-Public: 00380740189914
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 01/02/2024
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/13/2023; 01/08/2024
• 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