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	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d10 - concomitant product: alinity system software v3.5.1 was added as concomitant product.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 system logs and database were not provided.Technical product development (tpd) evaluated/ scanned the barcode label attached to the complaint and retrieved only the order no.Sid (b)(6).Reviewing the historical data in abbottlink (lis communication log) by the tpd indicated that the barcode contains only the order no.Sid (b)(6) and does not include the patient's name.Patient names in logs are obscured for security and privacy reasons, preventing any determination of how the name was recorded in the system.Consequently, there isn't enough information available to evaluate the issue further.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.Lastly, 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.
Event or Problem Description
The customer observed an incorrect patient name displayed on the alinity ci-series system control for one donor.When sample id (b)(6) (patient name (b)(6)) was loaded onto the system, the patient¿s name displayed as (b)(6) (incorrect) instead of (b)(6) (correct).The customer stated the patient¿s name in the laboratory information system (lis) was accurate.There was no impact to donor management reported.
Additional Manufacturer Narrative
Section a1: patient identifier: complete sample id is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed an incorrect patient name displayed on the alinity ci-series system control for one donor.When sample id: (b)(6) (patient name: (b)(6) was loaded onto the system, the patient¿s name displayed as (b)(6) (incorrect) instead of (b)(6) (correct).The customer stated the patient¿s name in the laboratory information system (lis) was accurate.There was no impact to donor management 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: 21815116
• Report Number: 3016438761-2025-00216
• Device Sequence Number: 8974710
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/12/2025

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: 03/24/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2019
• 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,
• Patient Sex: Unknown