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	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alinity i stat high sensitivity troponin-i results for multiple patients.The following data was provided (customer provided diagnostic cutoff is >/= 28 ng/l): (b)(6) 2026, sid (b)(6) (49 year old female): initial result = 46.8 ng/l, repeat = 96.1 ng/ml, repeat on another analyzer = 6.3 ng/l.(b)(6) 2026, sid (b)(6) (41 year old female): initial = 54.4 ng/l, repeat was < 2.7 ng/l, repeat on another analyzer was <2.7 ng/: a new sample was collected: sid (b)(6).Initial = 11.9 ng/l, repeat was <2.7 ng/l, repeat on another analyzer was <2.7 ng/l.The customer believes the results generated on the other analyzer are the correct results.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.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the module and observed a leaking syringe and a worn tubing (between sample pipettor probe to the pm sensor).The syringe assembly and tubing were replaced.The parts were determined to be cause of the falsely elevated alinity i stat high sensitivity troponin-i results.The module function was verified by acceptable control results.A review of complaint and trending data for the alinity i processing module, as well as the syringe assembly and the tubing (between sample pipettor probe to the pm sensor) did not identify any trends.A review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the alinity i processing module, serial number (b)(6), the syringe assembly, or the tubing (between sample pipettor probe to the pm sensor).
Event or Problem Description
The customer reported falsely elevated alinity i stat high sensitivity troponin-i results for multiple patients.The following data was provided (customer provided diagnostic cutoff is >/= 28 ng/l): (b)(6) 2026, sid (b)(6) (49 year old female), initial result = 46.8 ng/l, repeat = 96.1 ng/ml, repeat on another analyzer = 6.3 ng/l.(b)(6) 2026, sid (b)(6) (41 year old female): initial = 54.4 ng/l, repeat was < 2.7 ng/l, repeat on another analyzer was <2.7 ng/: a new sample was collected: sid (b)(6), initial = 11.9 ng/l, repeat was <2.7 ng/l, repeat on another analyzer was <2.7 ng/l.The customer believes the results generated on the other analyzer are the correct results.No impact to patient management was reported.

• 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: 50869570
• Report Number: 3016438761-2026-00529
• Device Sequence Number: 15797777
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: (01)00380740137366
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 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: 09/04/2026
• Initial Report FDA Received Date: 09/23/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALIN I HS TNI 200T US, 04Z21-25, 90391UD00; ALIN I HS TNI 200T US, 04Z21-25, 90391UD00
• Patient Sex: Unknown