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	03/05/2026
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.All available patient information was provided, no additional patient information was available.
Event or Problem Description
The customer reported a falsely elevated architect insulin result for a 35 year old male patient.The following data was provided: (b)(6) 2026, sid (b)(6): initial result was >300 uu/ml, repeat with 1:2 automatic dilution was >600 uu/ml the sample was sent to another laboratory which generated a result of 13.20 uu/ml with roche.No impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and supported the complaint issue.A review of tracking and trending for the architect insulin assay did not identify any trends related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 84221lp01.A review of the device history record did not identify any non-conformances, potential non-conformances, or deviations with the complaint lot and the complaint issue.Historical performance of the architect insulin reagent lot 84221lp01 was reviewed using field data from customers worldwide.The patient¿s data was analyzed and compared to an established control limit.The patient median result for lot 84221lp01 is within the established control limits; therefore, no unusual reagent lot performance was identified.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the architect insulin reagent, lot number 84221lp01.
Event or Problem Description
The customer reported a falsely elevated architect insulin result for a 35-year-old male patient.The following data was provided: (b)(6) 2026, sid (b)(6): initial result was >300 uu/ml, repeat with 1:2 automatic dilution was >600 uu/ml.The sample was sent to another laboratory which generated a result of 13.20 uu/ml with roche.No impact to patient management was reported.

• 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: 24638965
• Report Number: 3002809144-2026-00065
• Device Sequence Number: 15932328
• Product Code: CFP
• UDI-Device Identifier: 00380740169824
• UDI-Public: (01)00380740169824(17)261013(10)84221LP01
• 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): 04/03/2026

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: 08K41-28
• Device Lot Number: 84221LP01
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2025
• 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: 35 YR
• Patient Sex: Male