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	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated architect stat high sensitive troponin-i result for a patient sample.The following data was provided (customer¿s reference range 0-35 pg/ml): initial result = 101 pg/ml, repeat result on another architect = 3.5 pg/ml.Istat result = 3.5 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Additional information in sections d10 - concomitant product and h4 - device mfg date.The field service representative (fsr) inspected the instrument and observed that the arc sens lvl trg was cracked, which was replaced and resolved the issue.No additional discrepant result issues have been reported since the service activity was completed.An instrument service history review for (b)(6) revealed no additional service ticket associated with discrepant or erratic patient results.A review of complaint and trending data for the architect i2000sr did not identify any similar issues as described in this complaint.Additionally, a review of complaint and trending data associated with the arc sens lvl trg did not identify an increase in complaint activity.The device history record was reviewed, and no non-conformances or potential non-conformances were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect i2000sr, serial number (b)(6), or the arc sens lvl trg was identified.
Event or Problem Description
The customer observed a falsely elevated architect stat high sensitive troponin-i result for a patient sample.The following data was provided (customer¿s reference range 0-35 pg/ml): initial result = 101 pg/ml, repeat result on another architect = 3.5 pg/ml.Istat result = 3.5 pg/ml.No impact to patient management was reported.

• 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: 21525951
• Report Number: 3016438761-2025-00136
• Device Sequence Number: 9619067
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 03M74-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/31/2025
• 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 SENS LVL TRG, 08C94-66, UNKNOWN; ARC TROPONIN HS RGT 500, 02R98-35, (B)(6); ARC TROPONIN HS RGT 500, 02R98-35, (B)(6)
• Patient Sex: Unknown