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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive architect total b-hcg result for one patient sample generated on the architect i2000sr analyzer.The following data was provided: sid (b)(6): initial result = > 13000 miu/ml; repeat result = < 1.20 miu/ml.Colloidal gold method = negative.The customer¿s reference range for b-hcg: <5 for non-pregnant women.5-25 for early pregnancy.1-10 weeks from last menstrual period: 202-231000.11-15 weeks: 22536-234990.16-22 weeks: 8007-50064.23-40 weeks: 1600-49413.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.A1 - patient identifier: (b)(6) (completed sample id).All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The customer removed crystals at the sample probe which resolved the issue.There were no additional discrepant results reported on the architect, serial number (b)(6), after the cleaning was performed.A review of the architect (b)(6) service history identified no contributing factors to the discrepant result, nor did it identify any additional erratic, or discrepant results reported.A review of the architect immunoassay systems tracking and trending data revealed no systemic issues or trends associated with the discrepant result described in this complaint.A review of historical data for the architect part cleaned associated with this complaint, revealed no trends, systemic issues, or nonconformances.A review of labelling adequately addresses sample results observed problems for erratic / discrepant results, including, but not limited to the troubleshooting performed by the customer.Based on the investigation no product deficiency was identified for either the architect, serial number (b)(6).
Event or Problem Description
The customer reported a false positive architect total b-hcg result for one patient sample generated on the architect i2000sr analyzer.The following data was provided: sid (b)(6): initial result = > 13000 miu/ml; repeat result = < 1.20 miu/ml colloidal gold method = negative.The customer¿s reference range for b-hcg: <5 for non-pregnant women 5-25 for early pregnancy 1-10 weeks from last menstrual period: 202-231000 11-15 weeks: 22536-234990 16-22 weeks: 8007-50064 23-40 weeks: 1600-49413.There was no impact to patient management 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: 23744952
• Report Number: 3016438761-2025-00701
• Device Sequence Number: 8835480
• Product Code: JJE
• UDI-Device Identifier: 00380740006235
• UDI-Public: (01)00380740006235
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 03M74-02
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2017
• 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 BHCG 2000T (CN), 07K78-77, 71474UD02; ARC BHCG 2000T (CN), 07K78-77, 71474UD02
• Patient Sex: Unknown