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 Codes	Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated potassium results generated on the alinity c processing module for multiple samples.The following results were provided: potassium approximate reference (normal) range: 3.5 to 5.1 mmol/l 27may2024 sid (b)(6) initial result (ac01415) 6.97 mmol/l, repeat result (ac01108) 4.81 mmol/l.27may2024sid (b)(6) initial result (ac01415) 9.33 mmol/l, repeat result (ac01108) 3.70 mmol/l.27may2024sid (b)(6) initial result (ac01415) 6.94 mmol/l, repeat result (ac01108) 4.48 mmol/l.27may2024sid (b)(6) initial result (ac01415) 7.79 mmol/l, repeat result (ac01108) 3.86 mmol/l.27may2024sid (b)(6) initial result (ac01415) 6.92 mmol/l, repeat result (ac01108) 4.44 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier : sids (b)(6).All available patient information was included.Additional patient details are not available.Further investigation into this issue found this incident was impacted by an issue identified in alinity ci system software 3.6.1 and lower.The issue has the potential to generate incorrect results.Abbott is releasing alinity ci software version 3.7.0 to correct the issue and enhance the overall system.A product correction letter was issued on 13nov2025 to all alinity customers who have installed alinity c processing modules, notifying them of the issue.The product correction letter also provides the necessary steps to take if any of the potential issues are observed until they receive the mandatory upgrade of their alinity ci-series system software version 3.7.0.Root cause investigation is ongoing and the outcome of the investigation will be communicated through rcr# (b)(4).Note: this incident was previously reported under mfr 3016438761-2024-00338 for the alinity c processing module, list number 03r67-01.After further evaluation, the suspect medical device was changed to the alinity ci-series system control module, list number 03r70-01.
Additional Manufacturer Narrative
Section h6-medical device problem code were updated from a11 computer software problem to following.A0908 incorrect, inadequate or imprecise result or readings, a090809 high test results a11 computer software problem.
Event or Problem Description
The customer observed falsely elevated potassium results generated on the alinity c processing module for multiple samples.The following results were provided: potassium approximate reference (normal) range: 3.5 to 5.1 mmol/l.(b)(6) 2024, sid (b)(6), initial result (b)(6) 6.97 mmol/l, repeat result (b)(6) 4.81 mmol/l.(b)(6) 2024, sid (b)(6), initial result (b)(6) 9.33 mmol/l, repeat result (b)(6) 3.70 mmol/l.(b)(6) 2024, sid (b)(6), initial result (b)(6) 6.94 mmol/l, repeat result (b)(6) 4.48 mmol/l.(b)(6) 2024, sid (b)(6), initial result (b)(6) 7.79 mmol/l, repeat result (b)(6) 3.86 mmol/l.(b)(6) 2024, sid (b)(6), initial result (b)(6) 6.92 mmol/l, repeat result (b)(6) 4.44 mmol/l no impact to patient management was reported.

• 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: 23760682
• Report Number: 3016438761-2025-00706
• Device Sequence Number: 9933692
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230790
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3016438761-11192025/C/1
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNT CI SW V3.6.0, 04V20-27, UNKNOWN; ALNT CI SW V3.6.0, 04V20-27, UNKNOWN
• Patient Sex: Unknown