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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results for multiple patients.Results were released from the laboratory.Same sample was used for the repeat testing.The following results were provided: (customer provided reference range: : 9.00 to 20.00 pmol/l).(b)(6) 2026, sid (b)(6); initial result => 64.35 pmol/l, repeat results on (b)(6) 2026 (b)(6)= 19.72 pmol/l and 11sep2026= 20.22 pmol/l.(b)(6) 2026, sid: (b)(6); initial result = 22.55 pmol/l, repeat results on (b)(6) 2026 (b)(6)= 13.27 pmol/l.(b)(6) 2026, sid: (b)(6); initial result = 24.48 pmol/l, repeat results on (b)(6) 2026 (b)(6)= 13.18 pmol/l.No additional patient information was available.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.

• 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 ; +49()6122582960
• MDR Report Key: 50881801
• Report Number: 3016438761-2026-00532
• Device Sequence Number: 10754493
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: (01)00380740137366
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/24/2026

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: 09/14/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I FREE T4 1200T, 07P70-30, 88073UD00
• Patient Sex: Unknown