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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information from section a1 patient identifier: sid (b)(6).All available patient information has been included.No additional patient details are available.This report is being filed on an international product, list number 01l86-01 that has a similar product distributed in the us, list number 1l86-01 / 40 / 84 / 98, with 510k status of exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false reactive architect toxo igm and provided the following data: on (b)(6) 2025, sample id (b)(6), initial result was 5.07 (reactive) and repeat results were 0.05 (non-reactive) and 0.05 (non-reactive).Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The archictect i1000sr, serial # (b)(6) was evaluated it was determined that the trigger cap was damaged, and replacement of the arc sens lvl trg was required, which resolved the issue.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no additional complaints associated with the customer reported event.A review of tracking and trending did not identify an increase in complaint activity for the arc sens lvl trg with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues for the arc sens lvl trg as it relates to the customer reported event.Labeling was reviewed and was found to address the customer reported event.Based on the available information, no systemic issue or deficiency was identified for the archictect i1000sr, serial # (b)(6) arc sens lvl trg.
Event or Problem Description
The customer reported false reactive architect toxo igm and provided the following data: on (b)(6) 2025, sample id (b)(6) initial result was 5.07 (reactive) and repeat results were 0.05 (non-reactive) and 0.05 (non-reactive).Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.

• 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: 23390024
• Report Number: 3016438761-2025-00626
• Device Sequence Number: 9945286
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/10/2025

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: 10/07/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2010
• 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-M 100T, 06C20-25, 74389BE00; ARC TOXO-M 100T, 06C20-25, 74389BE00
• Patient Sex: Unknown