MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-01
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a false positive architect total -hcg result for a patient sample.The following data was provided (reference range <5 miu/ml is negative, >/= 25.00 miu/ml is positive): (b)(6) 2025 sample id (b)(6) initial result = 1423.66 miu/ml, (b)(6) 2025 repeat result = <1.20 miu/ml repeated 10 times on both architect analyzers and obtained all negative results.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section e1 - phone number complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
Additional information section h4 - device mfg date: updated from blank to 7/1/2005.The field service representative (fsr) inspected the instrument and performed extensive troubleshooting, including replacement of parts, but was unable to determine a single definitive likely cause of the issue.Therefore, the architect i2000sr, serial number (b)(6) was considered the likely cause.Return testing was not completed as returns were not available.The instrument service history review for (b)(6) revealed no additional tickets associated with discrepant/erratic 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 tracking and trending of the architect i2000sr did not identify an increase in complaint activity associated with the complaint issue.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect i2000sr for serial (b)(6) was identified.
Event or Problem Description
The customer observed a false positive architect total -hcg result for a patient sample.The following data was provided (reference range <5 miu/ml is negative, >/= 25.00 miu/ml is positive): (b)(6) 2025 sample id (b)(6) initial result = 1423.66 miu/ml, (b)(6) 2025 repeat result = <1.20 miu/ml repeated 10 times on both architect analyzers and obtained all negative results.No impact to patient management was reported.

• Brand Name: ARCHITECT I2000SR
• 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: 21524567
• Report Number: 3016438761-2025-00135
• Device Sequence Number: 8339956
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 03/20/2025

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: 03M74-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2005
• 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 RGT (100T), 07K78-25, (B)(6); ARC BHCG RGT (100T), 07K78-25, (B)(6)
• Patient Sex: Unknown