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	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier completed information: (b)(6).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 are not available.
Event or Problem Description
The customer observed falsely elevated alinity i insulin results for a patient who is currently under treatment on ozempic and displayed hypoglycemia.The patient reported they have never taken insulin and only ozempic.The following sids and insulin data results were provided for the same patient: (customer provided reference range <27 mu/l) on (b)(6) 2025, sid (b)(6), result = 114.76 mu/l.On (b)(6) 2025, sid (b)(6), result = 24.68 mu/l.On (b)(6) 2025, sid (b)(6), result = >300 mu/l diluted.On (b)(6) 2025, sid (b)(6), result =>600 mu/l.On (b)(6) 2025, sid (b)(6), result = >300 mu/l diluted.On (b)(6)2025, sid (b)(6), result = >300 mu/l.On (b)(6) 2025, sid (b)(6), result = >300 mu/l diluted.The roche result from sid (b)(6) = 11.2 mu/ml with reference range of 2.6-24.9 mu/l additionally, it was mentioned in addition to the ozempic the patient is also taking the following medications: colecalciferol, diclofenac, magnesium aspartate, multivitamin ¿ iron sulf, folic acid, paracetamol, pregabalin, gliclazide, amitriptyline, meloxicam, semaglutide.Additionally, it was mentioned no c-peptide was detected.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated alinity i insulin results for a patient who is currently under treatment on ozempic and displayed hypoglycemia.The patient reported they have never taken insulin and only ozempic.The following sids and insulin data results were provided for the same patient: (customer provided reference range <27 mu/l) on (b)(6)2025, sid (b)(6), result = 114.76 mu/l, on (b)(6)2025, sid (b)(6), result = 24.68 mu/l, on (b)(6) 2025, sid (b)(6), result = >300 mu/l diluted, on (b)(6) 2025, sid (b)(6), result =>600 mu/l, on (b)(6) 2025, sid (b)(6), result = >300 mu/l diluted, on (b)(6) 2025, sid (b)(6), result = >300 mu/l, on (b)(6) 2025, sid (b)(6), result = >300 mu/l diluted.The roche result from sid (b)(6) = 11.2 mu/ml with reference range of 2.6-24.9 mu/l.Additionally, it was mentioned in addition to the ozempic the patient is also taking the following medications: colecalciferol, diclofenac, magnesium aspartate, multivitamin ¿ iron sulf, folic acid, paracetamol, pregabalin, gliclazide, amitriptyline, meloxicam, semaglutide.Additionally, it was mentioned no c-peptide was detected.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity insulin results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the alinity i insulin assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 67511lp53.Device history record review for lot 67511lp53 did not show any potential non-conformances, deviations, or non-conformances.Labeling was reviewed and found to adequately address the issue under review.The overall performance of alinity i insulin assay was reviewed using data gathered from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 67511lp53 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 67511lp53.Based on the investigation, no systemic issue or deficiency of the alinity i insulin for lot number 67511lp53 was identified.All available patient information was included.Additional patient details are not available.

• 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: 21517725
• Report Number: 3002809144-2025-00070
• Device Sequence Number: 18227600
• Product Code: CFP
• UDI-Device Identifier: 00380740150815
• UDI-Public: (01)00380740150815(17)250530(10)67511LP53
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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): 03/26/2025

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: 05/30/2025
• Device Catalogue Number: 04T75-20
• Device Lot Number: 67511LP53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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