MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I INSULIN REAGENT KIT; RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Catalog Number	04T75-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed elevated alinity i insulin results.(b)(6) 2025: c-peptide: 22.2 ng/ml, insulin: 28.08 uu/ml, glucose: 117 (no unit of measurement provided).(b)(6) 2025: c-peptide: 43.96 ng/ml, insulin: 225.7 uu/ml, glucose: 131.Roche eclia method: c-peptide: 38.8 ng/ml, insulin: 247.1 uu/ml.(b)(6) 2026: sid (b)(6): c-peptide: 4.12 ng/ml, insulin: 6.4 uu/ml, glucose: 106.The patient is 77-year-old, male, with no abnormalities in glucose metabolism, and currently undergoing treatment for stomach cancer, with total gastrectomy performed in (b)(6).No impact to patient management was reported.
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed elevated alinity i insulin results.(b)(6) 2025: c-peptide: 22.2 ng/ml, insulin: 28.08 uu/ml, glucose: 117 (no unit of measurement provided).(b)(6) 2025: c-peptide: 43.96 ng/ml, insulin: 225.7 uu/ml, glucose: 131.Roche eclia method: c-peptide: 38.8 ng/ml, insulin: 247.1 uu/ml.(b)(6) 2026: sid (b)(6): c-peptide: 4.12 ng/ml, insulin: 6.4 uu/ml, glucose: 106.The patient is 77 year old, male, with no abnormalities in glucose metabolism, and currently undergoing treatment for stomach cancer, with total gastrectomy performed in december.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 alinity i insulin assay did not identify any trends related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 83511lp97.A review of the device history record did not identify any non-conformances, potential non-conformances, or deviations with lot 83511lp97 and the complaint issue.Historical performance of the alinity i insulin reagent lot 83511lp97 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 83511lp97 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 alinity i insulin reagent, lot number 83511lp97.

• Brand Name: ALINITY I INSULIN REAGENT KIT
• 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: 24507152
• Report Number: 3002809144-2026-00051
• Device Sequence Number: 13389317
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: (01)00380740150815(17)260924(10)83511LP97
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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 Expiration Date: 09/24/2026
• Device Catalogue Number: 04T75-20
• Device Lot Number: 83511LP97
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2025
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 77 YR
• Patient Sex: Male