MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY I PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R65-01
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed discrepant free t4, total psa and tsh results generated on the alinity i processing module for patient samples.The following data was provided: free t4 results: sample id (b)(6), initial = >5.00, repeat = 0.95.Total psa results: sample id (b)(6) initial = 1.53, repeat =9.09, sample id (b)(6) initial = 0.23, repeat =5.19, sample id (b)(6) initial = 0.05, repeat =1.34.Tsh results: sample id (b)(6) initial = 0.06, repeat = 2.25, sample id (b)(6) initial = 0.00, repeat = 0.49, sample id (b)(6) initial = 0.01, repeat = 0.38.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.The field service representative (fsr) inspected the instrument and replaced the trigger alinity ci sensor bsl, which resolved the issue.An instrument service history review for ai02619 revealed no additional tickets associated with discrepant/erratic results or message codes.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 i processing module did not identify any similar issues with regards to the customer reported event.Additionally, review of complaint and trending data associated with the alinity ci sensor bsl did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i processing module, serial number (b)(6), or the alinity ci sensor bsl, was identified.

• Brand Name: ALINITY I 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: 25178365
• Report Number: 3016438761-2026-00271
• Device Sequence Number: 10755929
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: (01)00380740137366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170317
• 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): 05/14/2026

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: 03R65-01
• 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: 04/26/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2019
• 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: ALIN I FREE T4 RGT 200T, 07P70-20, 80419UD00.; ALNTY I TSH RGT 200T KI, 07P48-20, 79343UD00.; ALNTY I TTL PSA 200T (J, 07P92-22, 79071FZ00.
• Patient Sex: Unknown