MAUDE Adverse Event Report: Abbott Laboratories Alinity c Processing Module; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R67-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported elevated magnesium generated from alinity c processing module (sn: (b)(6)) and provided the following data for a 51 year old female patient: on (b)(6)2026, sample id (b)(4) magnesium result was 6.2 mg/dl.Sample was retested on the analyzer and got a result of 1.9 mg/dl.Sample was also tested twice on another alinity c processing module (sn: (b)(6)) and results were 1.8 mg/dl and 1.9mg/dl.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The field service representative (fsr) resolved the issue by replacing multiple components, including the alinity c sample probe.During troubleshooting, gel contamination was observed within the sample probe pathway and on the tip of the sample probe.No additional discrepant result issues have been reported since the service activity was completed.The instrument service history review revealed no additional service ticket associated with discrepant/erratic patient results.There were 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 complaint and trending data for the alinity c processing module did not identify any similar issues as described in this complaint.Additionally, review of complaint and trending data associated with alinity c sample probe did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any nonconformances or potential nonconformances.Labeling was reviewed and adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c processing module for serial number (b)(6)or the alinity c sample probe was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: Alinity c Processing 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 ; +49()6122582960
• MDR Report Key: 50777717
• Report Number: 3016438761-2026-00507
• Device Sequence Number: 10705044
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: (01)00380740137380
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 03R67-01
• 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: 08/27/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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: ALNTY C MAG (720T), (b)(6)
• Patient Age: 51 YR
• Patient Sex: Female