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	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a false positive architect b-hcg result generated on an architect i2000sr analyzer for a 28-year-old female patient who was having a health examination.Sid (b)(6) ,initial result = 540.43 miu/ml, repeat result = <1.2 miu/ml.The customer reference range is 0-5 miu/ml.The instrument was inspected and tiny crystals were found on the sample probe.After cleaning the probe, the sample was repeated and generated a result = <1.2 miu/ml.The customer issued the result of <1.2 miu/ml.There was no impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed a false positive architect b-hcg result generated on an architect i2000sr analyzer for a 28-year-old female patient who was having a health examination.Sid (b)(6) initial result = 540.43 miu/ml, repeat result = <1.2 miu/ml.The customer reference range is 0-5 miu/ml.The instrument was inspected and tiny crystals were found on the sample probe.After cleaning the probe, the sample was repeated and generated a result = <1.2 miu/ml.The customer issued the result of <1.2 miu/ml.There was no impact to patient management.
Additional Manufacturer Narrative
Service was troubleshooting the issue and found crystals on the sample probe.Service cleaned the dirty/contaminated sample probe, which resolved the issue.The service history was reviewed and found no subsequent false positive b-hcg results have been reported since the current issue was identified.A review of trending data associated with the sample probe did not identify any trends.Additionally, a review of tracking and trending for the architect i2000sr analyzer did not identify any trends.Review of manufacturing documentation did not identify any non-conformances or potential non-conformances.Labeling was reviewed and adequately addressed the issue.Based on the investigation, no systemic issue or deficiency was identified for the architect i2000sr analyzer, (b)(6), nor the sample probe.

• 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: 24314711
• Report Number: 3016438761-2026-00074
• Device Sequence Number: 17362302
• 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): 03/09/2026

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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2017
• 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 100T (CN), 07K78-74, 78462UD01.; ARC BHCG 100T (CN), 07K78-74, 78462UD01.
• Patient Age: 28 YR
• Patient Sex: Female