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

Catalog Number	03M74-02
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated architect stat high sensitivity troponin-i and provided the following data for 1 patient: it was reported that a patient received treatment due to an elevated troponin result.The details of the treatment include that there was an unspecified medication used.The customer is not aware of any harm that occurred to the patient.The customer had no information regarding patient admitting diagnosis/chief complaint, past medical history, and reported that there was no information provided if the patient was experiencing any cardiac symptoms (i.E.Chest pain, abnormal ekg, etc.).The customer reported that there was no history of elevated troponin or cardiac issues/diagnoses.Age and gender not provided.Laboratory information: customer reference range is 3.5-7 ng/l.On (b)(6)2026: sid (b)(6) result was <4.Sid (b)(6) result was 664.It was reported that the patient received treatment.On (b)(6) 2026: sid: (b)(6) result was <4.When repeated on another analyzer, the result was <4.The sample that initially generated the elevated result (sample id (b)(6) was repeated on another analyzer and the result was <4.The elevated result was corrected to <4.No further impact to patient management was reported.
Additional Manufacturer Narrative
The customer inspected and replaced the arc, probe resolving the issue.Issue resolution was verified with passing qc and precision runs.The arc, probe was determined to be the likely cause of the issue.No additional result issues have been reported since the parts were replaced.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 tracking and trending of the architect i2000sr processing module and arc, probe did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect i2000sr processing module, serial number (b)(6), and arc, probe was identified.
Event or Problem Description
The customer observed falsely elevated architect stat high sensitivity troponin-i and provided the following data for 1 patient: it was reported that a patient received treatment due to an elevated troponin result.The details of the treatment include that there was an unspecified medication used.The customer is not aware of any harm that occurred to the patient.The customer had no information regarding patient admitting diagnosis/chief complaint, past medical history, and reported that there was no information provided if the patient was experiencing any cardiac symptoms (i.E.Chest pain, abnormal ekg, etc.).The customer reported that there was no history of elevated troponin or cardiac issues/diagnoses.Age and gender not provided.Laboratory information: customer reference range is 3.5-7 ng/l.On 7 feb 2026: sid (b)(6) result was <4.Sid (b)(6) result was 664.It was reported that the patient received treatment.On 8 feb 2026: sid: (b)(6) result was <4.When repeated on another analyzer, the result was <4.The sample that initially generated the elevated result (sample id (b)(6)) was repeated on another analyzer and the result was <4.The elevated result was corrected to <4.No further impact to patient management was reported.

• Brand Name: ARCHITECT I2000SR PROCESSING MODULE
• 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: 24489995
• Report Number: 3016438761-2026-00114
• Device Sequence Number: 13432407
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: (01)00380740006235
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/20/2026

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: 03M74-02
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2018
• 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, 81314UD00.; ARC TROPONIN HS RGT 500, 02R98-35, 81314UD00.
• Patient Sex: Unknown