MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for section a1 patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated architect toxo igg result for one patient with a history of being nonreactive.The following data was provided: (b)(6) 2025, sid (b)(6) (female patient): initial result = 143 iu/ml (reactive), repeat = nonreactive no impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect i1000sr, serial number (b)(6).The sample arc, probe was replaced and deemed the cause for the module generating the discrepant results.The replacement of the sample arc, probe was the issue resolution.The customer verified the system function with a control run.The service history of the (b)(6) verifies no subsequent discrepant patient result issues have been reported since the current issue was identified.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Review of tracking and trending did not identify an increase in complaint activity related to the complaint issue.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer reported a falsely elevated architect toxo igg result for one patient with a history of being nonreactive.The following data was provided: on (b)(6) 2025, sid (b)(6) (female patient): initial result = 143 iu/ml (reactive), repeat = nonreactive no impact to patient management was reported.

• Brand Name: ARCHITECT I1000SR 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: 23232672
• Report Number: 3016438761-2025-00583
• Device Sequence Number: 18329003
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/27/2025

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: 01L86-01
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2011
• 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: ARC TOXO-G RGT 100T, 06C19-25, 73690BE00; ARC TOXO-G RGT 100T, 06C19-25, 73690BE00
• Patient Sex: Female