MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT INSULIN; RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Catalog Number	08K41-28
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
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.A1 patient identifier: sample id is (b)(6).
Event or Problem Description
The customer reported falsely elevated architect insulin and provided the following data for a 49 year old female patient: on (b)(6) 2025 sample id (b)(6) result was >300 u/ml.The next day 1:2 dilution result was >600 u/ml.The sample was sent to another testing center, and generated a result of 18.10 u/ml.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely elevated architect insulin and provided the following data for a 49-year-old female patient: on (b)(6) 2025 sample id (b)(6) result was >300 u/ml.The next day 1:2 dilution result was >600 u/ml.The sample was sent to another testing center, and generated a result of 18.10 u/ml.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A ticket search for lot 80221lp88 did not identify an increase in complaint activity related to the issue under review.A review of tracking and trending for the architect insulin reagent did not identify any trends.Device history review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot number.The overall performance of architect insulin reagents in the field was reviewed using data gathered from customers worldwide.The patient¿s data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 80221lp88 is within the established control limits.Labeling review concludes that the issue is adequately addressed.Use error may have contributed to the customers issue as the assay package insert states do not compare result to other methods.Based on the investigation, no systemic issue or deficiency of the architect insulin assay, lot 80221lp88 was identified.

• Brand Name: ARCHITECT INSULIN
• Common Device Name: RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23500769
• Report Number: 3002809144-2025-00355
• Device Sequence Number: 8911359
• Product Code: CFP
• UDI-Device Identifier: 00380740169824
• UDI-Public: (01)00380740169824(17)260527(10)80221LP88
• 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): 12/08/2025

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 Expiration Date: 05/27/2026
• Device Catalogue Number: 08K41-28
• Device Lot Number: 80221LP88
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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 I1SR INTEG REFRB-SE, 01L87-97, (B)(6).; ARC I1SR INTEG REFRB-SE, 01L87-97, (B)(6).
• Patient Age: 49 YR
• Patient Sex: Female