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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer reported a falsely elevated architect intact pth result generated on the architect i1000sr analyzer for a 79-year-old female patient.The following data was provided: sample id (b)(6): initial intact pth result = 112.2 pg/ml the sample was sent to another laboratory and performed on an alinity platform = 37.50 pg/ml normal range = 6.7-38.8 pg/ml there was no impact to patient management reported.
Event or Problem Description
The customer reported a falsely elevated architect intact pth result generated on the architect i1000sr analyzer for a 79-year-old female patient.The following data was provided: sample id (b)(6): initial intact pth result = 112.2 pg/ml.The sample was sent to another laboratory and performed on an alinity platform = 37.50 pg/ml.Normal range = 6.7-38.8 pg/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
When troubleshooting the issue, service discovered the wash zone probe was dirty and the sample arc, probe calibration was off.The arc, probe and wash zone probe were both replaced and calibrated, which resolved the issue.Service history was reviewed and found no subsequent tickets for false elevated intact pth.Device history review of the arc, probe and wash zone probe did not identify any non-conformances or potential non-conformances.A complaint search for the arc, probe or wash zone probe did not identify any trends.A review of tracking and trending of the architect i1000sr did not identify any trends with regards to the complaint issue.Labeling was reviewed and adequately addressed the issue.Based on the investigation, no systemic issue or deficiency was identified for the architect i1000sr, (b)(6) or instrument parts.

• 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: 24501223
• Report Number: 3016438761-2026-00117
• Device Sequence Number: 10440595
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/17/2026

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: 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2014
• 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 IPTH REAGENT 100T, 08K25-28, (B)(6).; ARC IPTH REAGENT 100T, 08K25-28, (B)(6).
• Patient Age: 79 YR
• Patient Sex: Female