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	06/08/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported false reactive architect rhtlv-i/ii results for one patient sample generated on the architect i1000sr analyzer.The following data was provided: initial rhtlv i/ii result = 3.21 s/co; repeat results = 0.25 / 1.52 / 0.21 s/co (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive).There was no impact to patient management reported.
Additional Manufacturer Narrative
Service reviewed the instrument logs and determined the probe next r (03r85-01) was misaligned on the architect i1000sr, serial number (b)(6).The probe was calibrated, and the issue was resolved.No additional discrepant patient result issues have been reported since the service activity was completed.Return testing was not completed as returns were not available.The instrument service history review revealed no additional tickets associated with discrepant/erratic patient results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of complaint and trending data for the architect i1000sr did not identify any similar issues for discrepant results described in this complaint.Additionally review of complaint and trending data associated with the probe next r (03r85-01) did not identify an increase in complaint activity.Review of the manufacturing documentation did not identify any nonconformances or deviations related to the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the architect i1000sr for serial (b)(6) or the probe next r were identified.Upon review, updated d4 - primary udi number: from (b)(4).
Event or Problem Description
The customer reported false reactive architect rhtlv-i/ii results for one patient sample generated on the architect i1000sr analyzer.The following data was provided: initial rhtlv i/ii result = 3.21 s/co; repeat results = 0.25 / 1.52 / 0.21 s/co (reference range: < 1.00 s/co is nonreactive, >/= 1.00 s/co is reactive).There was no impact to patient management 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: 22346463
• Report Number: 3016438761-2025-00367
• Device Sequence Number: 15583380
• 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): 07/22/2025

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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2012
• 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 RHTLV I/II RGT 100T, 06L61-25, 67228BE00; ARC RHTLV I/II RGT 100T, 06L61-25, 67228BE00
• Patient Sex: Unknown