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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
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 provided, no additional patient information was available.
Event or Problem Description
The customer observed imprecise architect stat troponin-i results for two patients.The following data was provided: sid (b)(6), 73 year old male processed on (b)(6) 2026: initial result processed on architect serial number (b)(6) = 30 repeat 30.Sample was then processed on architect serial number (b)(6) results = 66 and 50.Sid (b)(6) 55 year old male processed on (b)(6) 2026: initial run on (b)(6) = 643(not reported) repeat = <20.Repeated on (b)(6) = <20.Redraw from same patient = <20 on both (b)(6).Customer¿s reference range = 0-30 ng/l no impact to patient management was reported.
Additional Manufacturer Narrative
Sections d3 email and g1 mfg site email were updated.After further evaluation, the suspect medical device was changed from architect (b)(6) processing module, list 01l86-40, abbott laboratories, irving, texas, usa, to the architect stat troponin-i, list 02k41-27, abbott gmbh, wiesbaden, germany.Mdr number 1415939-2026-00011-00 has been submitted, and all further information will be documented under that mdr number.
Event or Problem Description
The customer observed imprecise architect stat troponin-i results for two patients.The following data was provided: sid (b)(6), 73-year-old male processed on (b)(6) 2026: initial result processed on architect serial number (b)(6)= 30 repeat 30, sample was then processed on architect serial number (b)(6) results = 66 and 50.Sid (b)(6), 55-year-old male processed on (b)(6) 2026: initial run on (b)(6)= 643(not reported) repeat = <20, repeated on (b)(6)= <20, redraw from same patient = <20 on both (b)(6).Customer¿s reference range = 0-30 ng/l 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: 24327166
• Report Number: 3016438761-2026-00083
• Device Sequence Number: 9423616
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 01/29/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/23/2026
• 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, 85694UN25; ARC TROP RGT, 02K41-27, 85694UN25
• Patient Sex: Unknown