MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-01
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive architect total b-hcg result for a 22-year-old female who underwent a gynecological examination.The initial hcg result was 245.25 miu/ml (reference range: < 5 miu/ml).The customer retested the sample twice and generated both results of < 1.2 miu/ml.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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a false positive architect total b-hcg result for a 22-year-old female who underwent a gynecological examination.The initial hcg result was 245.25 miu/ml (reference range: < 5 miu/ml).The customer retested the sample twice and generated both results of < 1.2 miu/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and found a black dirt substance at the bottom of the buffer solution storage tank.The fsr cleaned the arc wash buffer r, resolving the issue.The module function was verified with a control run.The instrument service history review for (b)(6) verifies no subsequent discrepant patient result issues have been reported since the current issue was identified.A review of tracking and trending for the architect i1000sr did not identify an increase in complaint activity.A review of tracking and trending for the arc wash buffer r did not identify an increase in complaint activity.Review of the manufacturing documentation did not identify any 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 i1000sr for serial (b)(6) or the arc wash buffer r were identified.

• Brand Name: ARCHITECT I1000SR 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: 23426735
• Report Number: 3016438761-2025-00645
• Device Sequence Number: 20930644
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• 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): 11/05/2025

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: 01L86-01
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2019
• 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, 71453UD01; ARC BHCG 100T (CN), 07K78-74, 71453UD01
• Patient Age: 22 YR
• Patient Sex: Female