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	11/28/2025
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 has been included.No additional patient details are available.This report is being filed on an international product, list number 04t75 has a similar product distributed in the us, list number 04t75, which is 510k exempt.
Event or Problem Description
The customer observed falsely elevated alinity i insulin results for one patient who was diabetic.The patient is taking awiqli 700 units once a week.The following data was provided: the initial result from (b)(6) 2025 for sid (b)(6) was >300 uu/ml.The sample was repeated several times in automatic dilution on (b)(6) 2025 on another instrument (b)(6) and the result obtained was >600 uu/ml.The customer sent same sample to another laboratory with siemens instrument obtained the result of 18.4 uu/ml.The patients¿ blood glucose was 120 mg/dl and glucose was present in urine.From history to (b)(6) 2025 the patient had an alinity i insulin result of 10.7 uu/ml.The patient provided another sample and the alinity i insulin result for sid (b)(6) was >600 uu/ml; the siemens result was 8 uu/ml and the result obtained from another lab (unknown instrument) was 8 uu/ml.The physician also reports that last month the patient had elevated levels of pancreatic amylase and lipase, due to pancreatitis.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated alinity i insulin results for one patient who was diabetic.The patient is taking awiqli 700 units once a week.The following data was provided: the initial result from (b)(6) 2025 for sid (b)(6) was >300 uu/ml.The sample was repeated several times in automatic dilution on (b)(6) 2025 on another instrument (b)(6) and the result obtained was >600 uu/ml.The customer sent same sample to another laboratory with siemens instrument obtained the result of 18.4 uu/ml.The patients¿ blood glucose was 120 mg/dl and glucose was present in urine.From history to (b)(6) 2025 the patient had an alinity i insulin result of 10.7 uu/ml.The patient provided another sample and the alinity i insulin result for sid (b)(6) was >600 uu/ml; the siemens result was 8 uu/ml and the result obtained from another lab (unknown instrument) was 8 uu/ml.The physician also reports that last month the patient had elevated levels of pancreatic amylase and lipase, due to pancreatitis.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending for the alinity i insulin assay did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 82511lp96.Device history record review was performed, which did not show any potential non-conformances, deviations, or non-conformances for the complaint lot and issue.The overall performance of alinity i 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 82511lp96 is within the established control limits.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i insulin reagent lot 82511lp96 was identified.

• 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: 23815685
• Report Number: 3002809144-2025-00390
• Device Sequence Number: 18494030
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: (01)00380740150815(17)260908(10)82511LP96
• 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): 01/29/2026

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: 09/08/2026
• Device Catalogue Number: 04T75-20
• Device Lot Number: 82511LP96
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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 Sex: Unknown