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 Negative Result (1225)
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.All available patient information was included.Additional patient details were not provided.
Event or Problem Description
The customer observed multiple error codes (1005 unable to calculate result.Rlu outside lowest cal, 1007 error during activated measurement, 1011 error during foreground measurement) followed by a false negative hiv result generated on an architect i1000sr analyzer for one patient.Sid (b)(6), initial result = negative, repeat result on another architect = positive, no actual results were provided.There was no impact to patient management.
Event or Problem Description
The customer observed multiple error codes (1005 unable to calculate result.Rlu outside lowest cal, 1007 error during activated measurement, 1011 error during foreground measurement) followed by a false negative hiv result generated on an architect i1000sr analyzer for one patient.Sid v040527 initial result = negative, repeat result on another architect = positive, no actual results were provided.There was no impact to patient management.
Additional Manufacturer Narrative
Service inspected the instrument and found the arc snsr lvl pre was broken and only dispensing air.The arc snsr lvl pre was replaced and resolved the issue.The module function was verified with a control run.Instrument service history was reviewed and found no subsequent discrepant patient result issues or error codes have been reported since the current issue was identified.A review of complaint and trending data for the architect i1000sr processing module did not identify any similar issues as described in the complaint.Additionally, a review of complaint and trending data for the arc snsr lvl pre did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances for the part associated with this complaint.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the architect i1000sr, sn (b)(6), or the instrument part.

• 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: 23359738
• Report Number: 3016438761-2025-00618
• Device Sequence Number: 21104954
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2018
• 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 HIV AG/AB RGT 100T, 04J27-27, 77571BE00.; ARC HIV AG/AB RGT 100T, 04J27-27, 77571BE00.
• Patient Sex: Unknown