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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false reactive alinity i anti-hbc results generated on the alinity i processing module.The following data was provided: (43-year-old female) sid (b)(6) initial anti-hbc result 1.16 s/co, repeated 1.16 / 1.04 / 0.10 / 0.11 / 0.13 s/co.(48-year-old male) sid (b)(6) initial anti-hbc result 1.51 s/co, repeated 1.70 / 1.74 / 0.11 / 0.12 / 0.11 s/co.(31-year-old female) sid (b)(6) initial anti-hbc result 2.16 s/co, repeated 2.27 / 2.40 / 0.25 / 0.18 / 0.14 s/co.Sid (b)(6) initial result 1.28 s/co (reactive), repeated 1.44 and 1.35 s/co, sid (b)(6) initial result 1.00 s/co (reactive), repeated 1.22 and 1.15 s/co, sid (b)(6) initial result 1.13 s/co (reactive), repeated 1.30 and 1.41 s/co, sid (b)(6) initial result 2.67 s/co (reactive), repeated 2.78 and 0.11 s/co.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.A complaint investigation was conducted for the alinity i processing module (03r65-01), serial number (b)(6) to address the customer¿s observation of false reactive results.Service inspected the module and performed multiple troubleshooting activities including replacement of the trigger wash manifold valve and multiple trigger fluidic line fittings which resolved the issue.The instrument service history review revealed no additional tickets associated with discrepant/erratic patient results.A review of tracking and trending did not identify any trends for the alinity i processing module (03r65-01) with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and was found to address the customer reported issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity i processing module (03r65-01), serial number (b)(6).

• 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: 50947484
• Report Number: 3016438761-2026-00543
• Device Sequence Number: 18525126
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 09/30/2026

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: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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 I ANTI-HBC 1200T, 07P87-32, 83173BE00; ALNTY I ANTI-HBC 1200T, 07P87-32, 86460BE00
• Patient Sex: Unknown