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	03/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a.Patient information: no patient information is available.
Event or Problem Description
The customer observed a false positive architect total b-hcg for one patient.The following results were provided (reference range: <5 miu/ml): initial b-hcg result= 95.19 miu/ml; repeat result= <1.2 miu/ml.There was no impact to patient management reported.No patient information is available.
Additional Manufacturer Narrative
Update to section d3 - email: from (b)(4).The field service representative (fsr) inspected the architect i2000sr processing module, serial number (b)(6) and found dry serum/crystallization/particles at the pipetting opening for testing.The fsr cleaned the diverter, load and unload - moulded base (rohs), part number 7-205671-02, which was deemed the cause of the issue.The instrument service history review of the architect i2000sr verifies no subsequent false positive b-hcg results have been reported.A review of trending data associated with the diverter, load and unload - moulded base (rohs) did not identify any trends.A review of tracking and trending did not identify any trends for the architect i2000sr with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect i2000sr processing module for serial (b)(6) or the diverter, load and unload - moulded base (rohs) were identified.
Event or Problem Description
The customer observed a false positive architect total b-hcg for one patient.The following results were provided (reference range: <5 miu/ml): initial b-hcg result= 95.19 miu/ml; repeat result= <1.2 miu/ml.There was no impact to patient management reported.No patient information is available.

• 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: 24747759
• Report Number: 3016438761-2026-00182
• Device Sequence Number: 9166152
• 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): 04/22/2026

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: 03/22/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2016
• 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 100T (CN), 07K78-74, 80539UD01; ARC BHCG 100T (CN), 07K78-74, 80539UD01
• Patient Sex: Unknown