MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R70-01
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 - patient identifier: sids (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely elevated magnesium result generated by the alinity ci-series scm module for a patient.It was observed that the dilution factor was applied to add on orders, from a previous manual order.The following information was provided: (b)(6) 2025 sample id (b)(6) glucose result = >800, manual 1:5 dilution was ordered and result = 1300.Customer is not questioning this result and 1300 was reported out.Magnesium (mg) add on order for the same sid (b)(6) was completed on the lis beaker system.The 1:5 dilution factor was also applied to this order and result of 12 mg/dl was obtained.The customer was not aware that the dilution factor was still entered into the software when this result was run.Sample was run neat and result = 2.6 mg/dl.Customer¿s reference range is 1.8-2.6 mg/dl customer states that the same issue happened on (b)(6) 2025, a known ferritin sample (sample id (b)(6) that needs to be run diluted was run with manual 1:20 dilution.Ferritin result was not questioned or discrepant.There was an add on for cmp for the same sid, and all results had the 1:20 dilution factor applied which generated erroneous results.Customer did not report out cmp, reran sample neat and results were within normal range.No specific results and/or data for cmp was provided.No impact to patient management was reported.
Event or Problem Description
The customer observed a falsely elevated magnesium result generated by the alinity ci-series scm module for a patient.It was observed that the dilution factor was applied to add on orders, from a previous manual order.The following information was provided: (b)(6) 2025 sample id (b)(6) glucose result = >800, manual 1:5 dilution was ordered and result = 1300.Customer is not questioning this result and 1300 was reported out.Magnesium (mg) add on order for the same sid (b)(6) was completed on the lis beaker system.The 1:5 dilution factor was also applied to this order and result of 12 mg/dl was obtained.The customer was not aware that the dilution factor was still entered into the software when this result was run.Sample was run neat and result = 2.6 mg/dl.Customer¿s reference range is 1.8-2.6 mg/dl.Customer states that the same issue happened on (b)(6) 2025, a known ferritin sample (sample id (b)(6)) that needs to be run diluted was run with manual 1:20 dilution.Ferritin result was not questioned or discrepant.There was an add on for cmp for the same sid, and all results had the 1:20 dilution factor applied which generated erroneous results.Customer did not report out cmp, reran sample neat and results were within normal range.No specific results and/or data for cmp was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section h4 - device mfg date updated.The complaint investigation included a search for similar complaints, ticket trending review, and labeling review.Return testing was not completed as returns were not available.The customer observed an issue where a dilution factor from a previous test order was incorrectly applied to an add-on order on the alinity ci-series system control module (scm), (b)(6).The search for similar complaints found additional complaints related to the text query, however, there have been no subsequent tickets opened for dilution factor from a previous test order being incorrectly applied to an add-on order to the alinity ci-series system control module.A review of the result log was performed by the alinity software engineering team.The evaluation determined the information contained in the result log did not provide enough information to determine why the dilution factor from a previous manual order was applied to the add on order, however no additional issues were identified.A review of tracking and trending for the alinity system software did not identify an increase in complaint activity related to the complaint issue.The device history record was reviewed and also did not identify any non-conformances or potential non-conformances related to the current complaint.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified with the alinity ci-series system control module, serial number (b)(6), or the alinity system software v3.5.1.

• Brand Name: ALINITY CI-SERIES SYSTEM CONTROL MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22005427
• Report Number: 3016438761-2025-00284
• Device Sequence Number: 12525490
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K230790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: 03R70-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALNT CI SW V3.5.1, 04V20-25, UNKNOWN.; ALNT CI SW V3.5.1, 04V20-25, UNKNOWN.
• Patient Sex: Unknown