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	03/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.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.
Event or Problem Description
The customer observed falsely elevated architect troponin results on multiple patients.The result provided were: on (b)(6) 2025 sid (b)(6) initial=0.084 ng/ml /repeated= < 0.010 ng/ml.This patient was started on heparin due to falsely elevated troponin results.Sid (b)(6) initial= < 0.010 ng/ml /repeated=0.057 ng/ml /redrawn and repeated=0.010 ng/ml the customer believes that 0.057 ng/ml is discrepant troponin result for this patient.Laboratory reference range for troponin=0.00 to 0.028 ng/ml all patients are doing ok.No further impact to patient management.
Additional Manufacturer Narrative
During the requested site visit, the field service engineer (fse) replaced the arc sens lvl trg (list number 08c94-66) and valve, manifold kit (part number 7-77612-04) as likely cause for the issue, which resolved the issue.A review of the architect i processing module, serial number (b)(6) service history found identified no additional tickets regarding false elevated stat troponin-i patient results.A review of tracking and trending of the architect i processing module did not identify any trends associated with the complaint issue.A review of tracking and trending did not identify any trends for valve, manifold kit and sens lvl trg.The architect system operations manual addresses operational precautions and limitations and troubleshooting of the fluidics subsystem and addresses troubleshooting of elevated concentration and erratic sample results.The architect i system service manual contained adequate information for the troubleshooting, removal, replacement and verification of the valve, manifold kit and sens lvl trg.A review of historical data revealed no trends, systemic issues, or related nonconformances.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for either the architect i serial number (b)(6), or valve, manifold kit and sens lvl trg.
Event or Problem Description
The customer observed falsely elevated architect troponin results on multiple patients.The result provided were: on (b)(6) 2025, sid (b)(6), initial=0.084 ng/ml /repeated= < 0.010 ng/ml.This patient was started on heparin due to falsely elevated troponin results.Sid (b)(6), initial= < 0.010 ng/ml /repeated=0.057 ng/ml /redrawn and repeated=0.010 ng/ml.The customer believes that 0.057 ng/ml is discrepant troponin result for this patient.Laboratory reference range for troponin=0.00 to 0.028 ng/ml all patients are doing ok.No further impact to patient management.

• 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: 21921134
• Report Number: 3016438761-2025-00251
• Device Sequence Number: 20995404
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/02/2025

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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC TROP RGT, 02K41-27, 93900UN24; ARC TROP RGT, 02K41-27, 93900UN24
• Patient Sex: Unknown