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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a.Patient information: 31-year-old, female, 45-year-old, female, 55-year-old, female.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 reported falsely decreased architect tsh results generated by the architect i1000sr processing module for three patients.The samples were sent out to labcorp, yielding higher results.The following data was provided: normal range for tsh: 0.350 to 4.940 iu/ml.Patient 1 (31-year-old, female): architect tsh result = 0.3224 iu/ml; labcorp result = 1.930 ¿iu/ml.Patient 2 (45-year-old, female): architect tsh result = 0.3113 iu/ml; labcorp result = 1.84 iu/ml.Patient 3 (55-year-old, female): architect tsh result = 0.088 iu/ml; labcorp result = 0.703 iu/ml.No impact to patient management was reported.
Event or Problem Description
The customer reported falsely decreased architect tsh results generated by the architect i1000sr processing module for three patients.The samples were sent out to labcorp, yielding higher results.The following data was provided: normal range for tsh: 0.350 to 4.940 iu/ml patient 1 (31-year-old, female): architect tsh result = 0.3224 iu/ml; labcorp.Result = 1.930 iu/ml.Patient 2 (45-year-old, female): architect tsh result = 0.3113 iu/ml; labcorp.Result = 1.84 iu/ml.Patient 3 (55-year-old, female): architect tsh result = 0.088 iu/ml; labcorp.Result = 0.703 iu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The customer reported the architect i1000sr module, serial number (b)(6) generated falsely depressed architect tsh results after switching to the larger sst tubes.A single definitive cause of the discrepant results was not identified, although sample integrity could not be ruled out.The instrument service history review of the (b)(6) verified no subsequent issues have been reported related discrepant results after the current issue was identified.A review of tracking and trending for the architect i1000sr did not identify any trends with regards to the current issue.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.The architect system operations manual provides adequate labeling with regards customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect i1000sr processing module for serial (b)(6) was identified.

• 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: 23463924
• Report Number: 3016438761-2025-00648
• Device Sequence Number: 9084949
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/14/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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 TSH RGT 100T, 07K62-25, 73442UD00.; ARC TSH RGT 100T, 07K62-25, 73442UD00.
• Patient Age: 31 YR
• Patient Sex: Female