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	03/29/2026
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.Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported false elevated architect stat high sensitive troponin-i for 4 patients.The customer does not have specific patient information but states some patients were referred to another facility and the troponin results were negative.Some patients were treated with heparin.There was no reported harm to the patients.The following data was provided: sid (b)(6) female result from instrument (b)(6) = 0.039 ng/ml result from instrument (b)(6) = 0.008 ng/ml.Sid (b)(6) male result from instrument (b)(6) = 0.033 ng/ml result from instrument (b)(6) = 0.004 ng/ml.Sid (b)(6) male result from instrument (b)(6) = 0.029/0.019 result from instrument (b)(6) = 0.019.Sid 6330 male result from instrument (b)(6) = 0.048 result from instrument (b)(6) = 0.013.Female reference range 0.000-0.013.Male reference range 0.000-0.028 there was no further impact to patient management.
Additional Manufacturer Narrative
Updated email information in sections d3 - email and g1 - mfg site email.The field service representative (fsr) inspected the instrument, performed multiple trouble shooting procedures including part replacement.The architect i1000sr processing module, serial number (b)(6) was evaluated.An instrument service history review for (b)(6) revealed no additional 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 complaint and trending data for the architect i1000sr processing module did not identify any similar issues with regards to the customer reported event.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect i1000sr processing module, serial number (b)(6) was identified.
Event or Problem Description
The customer reported false elevated architect stat high sensitive troponin-i for 4 patients.The customer does not have specific patient information but states some patients were referred to another facility and the troponin results were negative.Some patients were treated with heparin.There was no reported harm to the patients.The following data was provided: sid (b)(6) female result from instrument (b)(6) = 0.039 ng/ml, result from instrument (b)(6) = 0.008 ng/ml.Sid (b)(6) male result from instrument (b)(6) = 0.033 ng/ml, result from instrument (b)(6) = 0.004 ng/ml.Sid (b)(6) male result from instrument (b)(6) = 0.029/0.019, result from instrument (b)(6) = 0.019.Sid (b)(6) male result from instrument (b)(6) = 0.048, result from instrument (b)(6) = 0.013.Female reference range 0.000-0.013.Male reference range 0.000-0.028 there was no further impact to patient management.

• 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: 24887353
• Report Number: 3016438761-2026-00216
• Device Sequence Number: 9851583
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/21/2026

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: 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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, 13763UN25.; ARC TROP RGT, 02K41-27, 13763UN25.
• Patient Sex: Unknown