MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This issue was previously reported under mdr number 3005094123-2025-00085-00 under a different suspect device.Section a1 - patient identifier complete entry = sample id (b)(6) and sample id (b)(6) all available patient information was included.Additional patient details are not available.Section e1 - phone complete entry = (b)(6).An abbott field service representative (fsr) was dispatched due to the customer reporting falsely elevated architect stat high sensitive troponin-i results on the architect i1000sr processing module, serial number (b)(6).During an extensive investigation, the fsr performed troubleshooting procedures, including part replacement, but was unable to determine a single definitive part for the likely cause of the issue.The architect i1000sr processing module, serial number (b)(6), was considered the likely cause.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency was identified.
Event or Problem Description
The customer observed falsely elevated architect stat high sensitive troponin-i results for two patients.The following data was provided: sample id (b)(6) initial result was 179.6 pg/ml, which was questioned by the physician, repeat result was <1.9 pg/ml.Sample id (b)(6) initial result was 52.2, repeat result was <1.9 pg/ml.There was no impact to patient management reported.

• Brand Name: ARCHITECT I1000SR 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: 21734159
• Report Number: 3016438761-2025-00201
• Device Sequence Number: 9002196
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 01L86-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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: RGT ARCH TROPONIN 100T, 03P25-27, 71169UD00
• Patient Sex: Unknown