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	04/24/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer observed positive alinity i havab igg results when processing on the alinity i processing module.Id (b)(6) (female, 38 years old) result 2.23 s/co positive, repeated result 0.37 s/co non-reactive.Id (b)(6) (male, 61 years old) - first result: 1.22 s/co reactive, repetition: 0.66 s/co nonreactive.Id (b)(6) (male, 26 years old) - first result: 1.83 s/co reactive, repetition: 0.71 s/co nonreactive.Id (b)(6) (male, 10 months) - first result: 1.75 s/co reactive, repetition: 0.42 s/co nonreactive.Id (b)(6) (female, 25 years old) - first result: 1.66 s/co reactive, repetition: 0.89 s/co nonreactive.Id (b)(6) (male, 27 years old) - first result: 1.36 s/co reactive, repetition: 0.68 s/co nonreactive.Id (b)(6) (female, 23 years old) - first result: 2.39 s/co reactive, repetition: 0.78 s/co nonreactive.Id (b)(6) (male, 23 years old) - first result: 5.52 s/co reactive, repetition: 0.47 s/co nonreactive.Id (b)(6) (female, 16 years old) - first result: 2.52 s/co reactive, repetition: 0.14 s/co nonreactive.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 ; 6122582960
• MDR Report Key: 25173454
• Report Number: 3016438761-2026-00267
• Device Sequence Number: 18676497
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: (01)00380740137366
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K170317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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 HAVAB IGG 1000T, 08P26-32, 79091BE00
• Patient Sex: Unknown