MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR PROCESSING MODULE, REFURBISHED; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-84
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect stat high sensitivity troponin-i results generated on the architect i2000sr processing module for a 49-year-old male patient.The patient was diagnosed with difficulty swallowing, shortness of breath, chest pain, and non-st-segment elevated myocardial infarction (nstemi).The patient was admitted to the hospital and the patient was given an aspirin 324 mg, rosuvastatin, esomeprazole, celecoxib, pa (posteroanterior) and lateral chest x-ray, electrocardiogram ekg (normal), and a ct (computed tomography) scan of the chest with contrast.The following results were provided: (customer provided normal reference range 0-35 pg/ml) on (b)(6) 2026 sid (b)(6) initial 103.5 pg/ml, repeat result on both instruments = <3.5 pg/ml the customer reported they believe the correct result is <3.5 pg/ml.No further impact to patient management was reported.
Additional Manufacturer Narrative
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 falsely elevated architect stat high sensitivity troponin-i results generated on the architect i2000sr processing module for a 49-year-old male patient.The patient was diagnosed with difficulty swallowing, shortness of breath, chest pain, and non-st-segment elevated myocardial infarction (nstemi).The patient was admitted to the hospital and the patient was given an aspirin 324 mg, rosuvastatin, esomeprazole, celecoxib, pa (posteroanterior) and lateral chest x-ray, electrocardiogram ekg (normal), and a ct (computed tomography) scan of the chest with contrast.The following results were provided: (customer provided normal reference range 0-35 pg/ml).(b)(6) 2026 sid (b)(6) initial 103.5 pg/ml, repeat result on both instruments = <3.5 pg/ml.The customer reported they believe the correct result is <3.5 pg/ml.No further impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section d10 concomitant product the instrument service history review for the architect i2000sr processing module serial number (b)(6) found no additional complaint tickets related to discrepant troponin results.Data and information provided by the customer were reviewed and support the complaint issue.A review of complaint and trending data for the architect i2000sr processing module did not identify any similar issues related to the current issue.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances related to the current complaint.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect i2000sr processing module for serial number (b)(6) was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ARCHITECT I2000SR PROCESSING MODULE, REFURBISHED
• 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: 24412745
• Report Number: 3016438761-2026-00104
• Device Sequence Number: 5880087
• Product Code: JJE
• UDI-Device Identifier: 00380740107222
• UDI-Public: (01)00380740107222
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/12/2026

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: 03M74-84
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2011
• 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 TROPONIN HS RGT 500, 02R98-35, 81773UD00
• Patient Age: 49 YR
• Patient Sex: Male