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	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect stat high sensitivity troponin-i result for one patient.Results were not reported to the medical provider.The following data was provided (customer¿s normal range is 0.030-0.118 ng/ml): on (b)(6) 2025, sample id: (b)(6); 1st draw results= 0.013 ng/ml.On (b)(6) 2025, sample id: (b)(6); 2nd draw results = 0.181, < 0.010 on this instrument & < 0.010 on the architect i1000, sn: (b)(6).There was no impact to patient management reported.
Additional Manufacturer Narrative
Complete information for section a1: patient identifier: sid: (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from the architect i1000 analyzer, list number 01l86-40 to the architect troponin reagent 2k41-27, lot 36403un25.Mdr number 1415939-2025-00026 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer observed a falsely elevated architect stat high sensitivity troponin-i result for one patient.Results were not reported to the medical provider.The following data was provided (customer¿s normal range is 0.030-0.118 ng/ml): on (b)(6) 2025, sample id (b)(6); 1st draw results= 0.013 ng/ml.On (b)(6) 2025, sample id (b)(6); 2nd draw results = 0.181, < 0.010 on this instrument & < 0.010 on the architect i1000, sn (b)(6).There was no impact to patient management 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: 22953588
• Report Number: 3016438761-2025-00504
• Device Sequence Number: 21230358
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 08/23/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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 SENS LV PTRG, 08C94-67, UNKNOWN,; ARC SENS LV PTRG, 08C94-67, UNKNOWN,; ARC SENS LV PTRG, 08C94-67, UNKNOWN.; ARC TROPONIN HS RGT 100, 02R98-25, 36403UN25,; ARC TROPONIN HS RGT 100, 02R98-25, 36403UN25,; ARC TROPONIN HS RGT 100, 02R98-25, 36403UN25,
• Patient Sex: Unknown