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	10/22/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer observed a false positive architect total -hcg result generated for a 28-year-old female patient sample.The following data was provided (reference range <5 miu/ml is negative): sample id (b)(6), initial result = 373.87 miu/ml, repeat result = <1.2 miu/ml.Same patient, new sample obtained the next day and result = <1.2 miu/ml.No impact to patient management was reported.
Event or Problem Description
The customer observed a false positive architect total hcg result generated for a 28-year-old female patient sample.The following data was provided (reference range <5 miu/ml is negative): sample id: (b)(6) initial result = 373.87 miu/ml, repeat result = <1.2 miu/ml.Same patient, new sample obtained the next day and result = <1.2 miu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section h4: device mfg date.The field service representative (fsr) inspected the instrument and performed troubleshooting.Black impurities at the bottom of the reservoir, buffer was observed.Service cleaned the reservoir, buffer removing the bubbles in the line.The instrument service history review revealed no additional tickets associated with discrepant or erratic patient results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.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 reservoir, buffer did not identify an increase in complaint activity.Review of the manufacturing documentation did not identify any non-conformance's or potential non-conformance's 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, serial number: (b)(6), or the reservoir, buffer were identified.

• 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: 23485231
• Report Number: 3016438761-2025-00657
• Device Sequence Number: 10559101
• 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): 11/26/2025

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: 10/22/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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, 71543UD01.; ARC BHCG 100T (CN), 07K78-74, 71543UD01.
• Patient Age: 28 YR
• Patient Sex: Female