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

Catalog Number	01L86-40
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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.
Event or Problem Description
The customer reported a false positive architect total b-hcg result for a 24 year old female patient.The following data was provided: on (b)(6) 2025, sid (b)(6): initial result = 378.798 iu/l, repeat testing was negative twice the patient was redrawn twice, and both results were negative.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative inspected the architect i1000sr processing module, serial number: (b)(6) and replaced multiple parts, including the arc, probe due to buildup on top of the pipettor probe, resulting in crash sensor assembly getting stuck.The replacement of the arc, probe resolved the issue.The service history of the (b)(6) verifies no subsequent discrepant patient result issues have been reported since the current issue was identified.A review of tracking and trending of the architect i1000sr processing module did not identify an increase in complaint activity associated with the complaint issue.A review of tracking and trending for the arc, probe did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect i1000sr processing module, serial number: (b)(6) the arc, probe was identified.
Event or Problem Description
The customer reported a false positive architect total b-hcg result for a 24-year-old female patient.The following data was provided: on (b)(6) 2025, sid: (b)(6): initial result = 378.798 iu/l, repeat testing was negative twice.The patient was redrawn twice, and both results were negative.No impact to patient management was reported.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED)
• 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: 23407656
• Report Number: 3016438761-2025-00637
• Device Sequence Number: 18396941
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/11/2025

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: 01L86-40
• 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: 10/11/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2015
• 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, UNKNOWN.; ARC BHCG RGT (100T), 07K78-25, UNKNOWN.
• Patient Age: 24 YR
• Patient Sex: Female