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

Catalog Number	01L86-40
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results generated for a 55-year-old female patient sample.The following data was provided (customer¿s reference range 0.00-0.05 ng/ml).B)(6) 2025; sample id (b)(6) result = 1.00 ng/ml, repeat result on another instrument i1sr56588 = 0.00 ng/ml.Same patient: sample id (b)(6) result = 0.00 ng/ml, repeat result on another instrument i1sr56588 = 0.00 ng/ml.Sample id (b)(6) was initially run multiple times on 2 different instruments, and every time it generated instrument error message 3350 unable to process test, aspiration error for (pipetter) at (sh sample).No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Additional information section h4 - device mfg date: updated from blank to 3/29/2016.Service reviewed the instrument logs and recommended the customer clean the arc, probe.The customer inspected the sample and found a clot in the sample.Poor sample integrity likely contributed to the falsely elevated result, aspiration errors, and clogged probe.The instrument service history review for (b)(6) revealed no additional service tickets associated with discrepant/erratic 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 tracking and trending of the architect i1000sr did not identify an increase in complaint activity associated with the complaint issue.A review of tracking and trending for the arc, probe did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation the architect i1000sr, serial number (b)(6), and arc, probe, are performing as intended.No systemic issue or deficiency of the architect i1000sr for serial (b)(6), or the arc, probe, were identified.
Event or Problem Description
The customer observed falsely elevated architect stat troponin-i results generated for a 55-year-old female patient sample.The following data was provided (customer¿s reference range 0.00-0.05 ng/ml) on (b)(6) 2025, sample id (b)(6), result = 1.00 ng/ml, repeat result on another instrument (b)(6) = 0.00 ng/ml.Same patient: sample id (b)(6), result = 0.00 ng/ml, repeat result on another instrument (b)(6) = 0.00 ng/ml.Sample id (b)(6) was initially run multiple times on 2 different instruments, and every time it generated instrument error message 3350 unable to process test, aspiration error for (pipetter) at (sh sample).No impact to patient management was reported.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED)
• 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: 22798124
• Report Number: 3016438761-2025-00473
• Device Sequence Number: 8512321
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/04/2025

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: 01L86-40
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2016
• 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 TROP RGT, 02K41-27, 19415UN25; ARC TROP RGT, 02K41-27, 19415UN25; ARC, PROBE, 08C94-47,; ARC, PROBE, 08C94-47,
• Patient Age: 55 YR
• Patient Sex: Female