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	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed the urea nitrogen assay parameters automatically downloaded incorrectly to the alinity ci system control module after a software update.The customer observed after the software update on (b)(6) 2024 at 2:00 p.M.The correlation factor was restored to 1 with no notification while keeping the linearity limits appropriate for the correlation factor of 2.14.After the customer ran quality controls, the urea nitrogen results were low compared to the expected means.The results were not multiplied by the expected correlation factor of 2.14 and were not aligned with the customer¿s references.After correcting the factor, it was necessary to recalibrate the assay so that it was applied to the results.The following sids were provided: (b)(6) however, no specific data results were provided at this time.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of complaint text, a search for similar complaints, trending data, labeling, and device history records review.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.A review of tracking and trending did not identify any trends for the issue under review.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Review of the alinity operations manual provides adequate labeling on how to install assay files on the instrument which includes steps on how to print the assay-specific installation information (alinity c urea assay file document).Review of the alinity c urea assay file document provides information regarding specific installation requirements.It mentioned that for assay file versions that differ from the previous file versions and that require installation or reinstallation, all customer-configured parameters are retained except the following parameters: run calibrations for reagents by lot or kit, calibrator replicates, full calibration interval, slope limit for ict assays, correlation factor, and intercept.Review of the alinity operations manual and alinity c urea assay file document revealed that the system is working as designed.Based on the investigation, the alinity ci-series scm module, serial number (b)(6) is performing as intended at the customer site, therefore, there is no systemic issue or deficiency of the alinity ci-series scm module, serial number (b)(6) was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed the urea nitrogen assay parameters automatically downloaded incorrectly to the alinity ci system control module after a software update.The customer observed after the software update on (b)(6) 2024 at 2:00 p.M.The correlation factor was restored to 1 with no notification while keeping the linearity limits appropriate for the correlation factor of 2.14.After the customer ran quality controls, the urea nitrogen results were low compared to the expected means.The results were not multiplied by the expected correlation factor of 2.14 and were not aligned with the customer¿s references.After correcting the factor, it was necessary to recalibrate the assay so that it was applied to the results.The following sids were provided; (b)(6) however, no specific data results were provided at this time.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: 20588216
• Report Number: 3016438761-2024-00642
• Device Sequence Number: 12997831
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• 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): 11/19/2024

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: 03R70-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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