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	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.The incident involved a use error as the alinity c processing module flagged the initial result (>) to warn the user the result was suspect, and the flagged result was released out of the laboratory.However, the complaint investigation concluded that high concentration waste (hcw) drain on the alinity c processing module was contaminated/dirty.Abbott service performed troubleshooting on the alinity c processing module (b)(6) and found the high concentration waste drain was contaminated/dirty.Service cleaned the tubing, peristaltic head (rohs) which resolved the issue.The module function was verified with a control run.The service history of the (b)(6) found no additional false elevated patient results were reported after the current event was identified.Review of trending data did not identify a trend for the tubing, peristaltic head (rohs) or the alinity c processing module with regards to the current issue.Review of the corrective and preventive actions system found no non-conformances for the tubing, peristaltic head (rohs).Labeling was reviewed and found to adequately address operational precautions and limitations; component replacement; and troubleshooting for erratic results as well as information for the troubleshooting of tubing, peristaltic head (rohs).Based on the investigation no systematic issue or deficiency was identified for the alinity c processing module or the tubing, peristaltic head (rohs).
Event or Problem Description
The following incident describes a use error.The customer reported falsely elevated magnesium generated from alinity c processing module and provided the following data: on (b)(6) 2026, sample id (b)(6) (male, 60 years old) first value > 3.9mmol/l, retest result was 0.67 mmol/l.Resutls generated from sn: (b)(6).The measuring interval of the magnesium assay is 0.25 mmol/l to 3.90 mmol/l.There was no reported impact to patient management.

• 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 ; 6122582960
• MDR Report Key: 25544669
• Report Number: 3016438761-2026-00338
• Device Sequence Number: 13447176
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: (01)00380740137380
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: 06/12/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2017
• 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), 08P19-25, 82278UD00.
• Patient Age: 60 YR
• Patient Sex: Male