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	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6).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 observed a false elevated architect stat troponin-i result generated on the architect i1000sr processing module for two patient samples.The following results were provided: (customer provided reference range: <=0.03 ng/ml, critical range: >=0.30 ng/ml 06nov2025 sid (b)(6) 29-year-old female patient: initial result = 0.82 ng/ml, new sample result = <0.01 ng/ml original specimen repeated on their other analyzer, and it resulted = <0.01 ng/ml 12nov2025 sid (b)(6) 33-year-old male patient initial result = 0.38 ng/ml, result 2 hours later = <0.01 ng/ml no impact to patient management was reported.
Event or Problem Description
The customer observed a false elevated architect stat troponin-i result generated on the architect i1000sr processing module for two patient samples.The following results were provided: (customer provided reference range: =0.03 ng/ml, critical range: =0.30 ng/ml.(b)(6) 2025 sid (b)(6) 29-year-old female patient: initial result = 0.82 ng/ml, new sample result = 0.01 ng/ml.Original specimen repeated on their other analyzer, and it resulted = <0.01 ng/ml.(b)(6) 2025 sid (b)(6) 33-year-old male patient initial result = 0.38 ng/ml, result 2 hours later = 0.01 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from the architect i1000sr processing module (integrated) to architect stat troponin-i.Mdr number 1415939-2026-00002 has been submitted and all further information will be documented under that mdr number.

• 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: 23679536
• Report Number: 3016438761-2025-00693
• Device Sequence Number: 15877908
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/09/2026

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: 11/07/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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, 66709UN25; ARC TROP RGT, 02K41-27, 66709UN25; VALVE, BYPASS, 2 WAY (ROHS), 7-200607-01, UNKNOWN; VALVE, BYPASS, 2 WAY (ROHS), 7-200607-01, UNKNOWN
• Patient Sex: Unknown