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); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.A1 - patient identifier: (b)(6) (2 total patients).
Event or Problem Description
The customer reported that on (b)(6)2024, two patient samples were tested for a basic chemistry panel.The 2 samples were both run correctly on the alinity c processing module, however once the results were transmitted from the instrument to the alinity ci-series system control, both patients had the same the results.The following information was provided: both samples were run on alinity c processing module (sn (b)(6)).Patient #1: sid (b)(6) (diabetic).Patient #2: sid (b)(6) (non-diabetic).The physician for the diabetic patient (sid (b)(6)) notified the customer and said this patient never had a glucose under 200 mg/dl.The customer looked back at the instrument logs and the actual result from the instrument was 270 mg/dl which belonged to the diabetic patient (sid (b)(6)).The glucose result of 66 mg/dl belonged to patient #2 (sid (b)(6)).The customer stated that it appeared when the results were transmitted from the instrument to the alinity ci-serires system control, the results from sid (b)(6) was used for both patients.The patient¿s chart has been amended for sid (b)(6).There was no further impact to patient management reported.
Event or Problem Description
The customer reported that on (b)(6) 2024, two patient samples were tested for a basic chemistry panel.The 2 samples were both run correctly on the alinity c processing module, however once the results were transmitted from the instrument to the alinity ci-series system control, both patients had the same the results.The following information was provided: both samples were run on alinity c processing module (sn (b)(6)).Patient #1: sid (b)(6) (diabetic).Patient #2: sid (b)(6) (non-diabetic).The physician for the diabetic patient (sid (b)(6)) notified the customer and said this patient never had a glucose under 200 mg/dl.The customer looked back at the instrument logs and the actual result from the instrument was 270 mg/dl which belonged to the diabetic patient (sid (b)(6)).The glucose result of 66 mg/dl belonged to patient #2 (sid (b)(6)).The customer stated that it appeared when the results were transmitted from the instrument to the alinity ci-serires system control, the results from sid (b)(6) was used for both patients.The patient¿s chart has been amended for sid (b)(6).There was no further impact to patient management reported.
Additional Manufacturer Narrative
The abbott informatics group reviewed the ics logs and confirmed that the instrument transmitted the correct results to the lis.No impact to patient management was reported.The investigation determined that the alinity c system, including the system control module, functioned as designed.Return testing was not completed as returns were not available.The instrument service history review for (b)(6) revealed no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending for the alinity ci-series system control module did not identify an increase in complaint activity.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity ci-series system control module for serial (b)(6) was identified.The instrument performed as intended at the customer site.No malfunction and no product deficiency were 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: 21057048
• Report Number: 3016438761-2025-00002
• Device Sequence Number: 8136340
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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