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	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false reactive alinity i havab igg ii results for multiple patients.The following data was provided: (b)(6) 2026, sid (b)(6) (19-year-old male): initial result on (b)(6) = positive, repeat on another alinity = negative.(b)(6) 2026, sid (b)(6) (33-year-old male): initial result on (b)(6) = positive, repeat = negative, repeat on another alinity = negative.Additionally, the customer noted a shift up in quality controls.A precision study was completed with sid (b)(6) for troubleshooting purposes: (b)(6) = 0.3, (b)(6) = 0.75, (b)(6) = 0.43, (b)(6) = 1.32, (b)(6) = 0.53, (b)(6) = 1.09, (b)(6) = 0.28, (b)(6) = 1.07, (b)(6) = 0.41, (b)(6) = 0.4.A patient comparison study was completed for troubleshooting purposes: sample 1: (b)(6) = 10.8, (b)(6) = 9.61, sample 2: (b)(6) = 0.14, (b)(6) = 0.12, sample 3: (b)(6) = 7.25, (b)(6) = 7.48, sample 4: (b)(6) = 9.08, (b)(6) = 8.53, sample 5: (b)(6) = 8.07, (b)(6) = 8.18, sample 6: (b)(6) = 11.03, (b)(6) = 10.20, sample 7: (b)(6) = 1.26, (b)(6) = 0.73, sample 8: (b)(6) = 0.34, (b)(6) = 0.34, sample 9: (b)(6) = 0.09, (b)(6) = 0.10, sample 10: (b)(6) = 0.21, (b)(6) = 0.27.There was no impact to patient management reported.
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• 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: 25112123
• Report Number: 3016438761-2026-00260
• Device Sequence Number: 10390883
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: (01)00380740137366
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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 HAV-IGG RGT 200, 06S93-21, 79100BE00; ALNTY I HAV-IGG RGT 200, 06S93-21, 79100BE00
• Patient Sex: Unknown