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	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a software issue on the alinity ci-series system control module in which the comma/decimal configuration incorrectly caused a falsely depressed result for ck.The ck result showed 6.230 u/l and should be 6230 u/l.The result was not released as during validation of the result the customer noticed it did not match the patient history.The field service representative had replaced the drive due to a blue screen error and after installing sw 3.6 did not change the configuration from the default to the customer¿s previous configuration for comma/decimal.The setting has been corrected.There was no impact to patient management reported.
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 observed a software issue on the alinity ci-series system control module in which the comma/decimal configuration incorrectly caused a falsely depressed result for ck.The ck result showed 6.230 u/l and should be 6230 u/l.The result was not released as during validation of the result the customer noticed it did not match the patient history.The field service representative had replaced the drive due to a blue screen error and after installing sw 3.6 did not change the configuration from the default to the customer¿s previous configuration for comma/decimal.The setting has been corrected.There was no impact to patient management reported.
Additional Manufacturer Narrative
The customer reported false depressed ck results after installing sw 3.6 the field service representative did not change the configuration from the default to the customer¿s previous configuration for comma/decimal on the alnty ci-series sys cnt (list number 03r70-01), serial # (b)(6).The issue was resolved with the assay parameter configuration corrected.The alnty ci-series sys cnt (list number 03r70-01), serial # (b)(6) was deemed the likely cause for the issue and the subject of this investigation.The service history of the alinity ci, serial #(b)(6) verifies no subsequent false depressed ck result issues have been reported due to incorrect assay configuration.A device history record was reviewed and did not identify any non-conformances or potential non-conformances related to the issue under review.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation no systemic issue or deficiency with the alnty ci-series sys cnt (list number 03r70-01), serial # (b)(6) was identified.

• 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: 22417191
• Report Number: 3016438761-2025-00381
• Device Sequence Number: 6979387
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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