MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE REAGENT KIT

Catalog Number	01L75-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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 was included.Additional patient details are not available.
Event or Problem Description
The customer reported falsely elevated architect cyclosporine results for a 24-year-old patient undergoing treatment for aplastic anemia with cyclosporine.The patient took cyclosporine (tianke) 100g once every 12 hours.The specific time of blood draw was not able to be provided by the physician.The following cyclosporine results were provided: trough result = 87.9 ng/ml peak result = 743.30 ng/ml the physician felt that the peak result was too high in comparison to the patient¿s previous peak values in past clinical history.The qc was within range.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation 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 in-house testing with retained kit of the complaint lot.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.A ticket search for lot 66278fp00 did not identify an increase in complaint activity related to falsely elevated results.Review of tracking and trending for the architect cyclosporine 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 66278fp00.Device history record review was performed and did not identify any non-conformances or deviations associated with lot 66278fp00 and the complaint issue.In-house accuracy testing was completed using panels which mimic patient samples using a retained kit of lot number 66278fp00.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the architect cyclosporine reagent lot 66278fp00 was identified.
Event or Problem Description
The customer reported falsely elevated architect cyclosporine results for a 24-year-old patient undergoing treatment for aplastic anemia with cyclosporine.The patient took cyclosporine (tianke) 100g once every 12 hours.The specific time of blood draw was not able to be provided by the physician.The following cyclosporine results were provided: trough result = 87.9 ng/ml peak result = 743.30 ng/ml the physician felt that the peak result was too high in comparison to the patient¿s previous peak values in past clinical history.The qc was within range.There was no impact to patient management reported.

• Brand Name: ARCHITECT CYCLOSPORINE REAGENT KIT
• Common Device Name: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 21071790
• Report Number: 1415939-2025-00001
• Device Sequence Number: 18219439
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: (01)00380740001315(17)250529(10)66278FP00
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080751
• 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): 02/21/2025

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: 05/29/2025
• Device Catalogue Number: 01L75-25
• Device Lot Number: 66278FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Age: 24 YR
• Patient Sex: Unknown