MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE REAGENT KIT

Catalog Number	01L75-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
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 observed falsely depressed architect cyclosporine results generated on the architect i2000sr processing module for multiple samples.The following results from (b)(6) 2024 were provided: initial result = 72.8 ng/ml, repeat result = 154.9 ng/ml initial result = 71.5 ng/ml, repeat result = 181.3 ng/ml initial result = 53.2 ng/ml, repeat result = 153.7 ng/ml initial result = 77.4 ng/ml, repeat result = 211.9 ng/ml initial result = 48.3 ng/ml, repeat result = 162.9 ng/ml initial result = 60.2 ng/ml, repeat result = 244.9 ng/ml no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed architect cyclosporine 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 in house testing.Data and information provided by the customer were reviewed and support the complaint issue.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.The device history record review did not identify any nonconformances, potential non-conformances or deviations associated with lot number 63163fp00 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.In house testing of the intended storage stability was performed and the intended storage stability for reagent lot 63163fp00 met all specifications.Based on the investigation, no systemic issue or deficiency with the architect cyclosporine assay for lot 63163fp00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed architect cyclosporine results generated on the architect i2000sr processing module for multiple samples.The following results from 14oct2024 were provided: initial result = 72.8 ng/ml, repeat result = 154.9 ng/ml initial result = 71.5 ng/ml, repeat result = 181.3 ng/ml initial result = 53.2 ng/ml, repeat result = 153.7 ng/ml initial result = 77.4 ng/ml, repeat result = 211.9 ng/ml initial result = 48.3 ng/ml, repeat result = 162.9 ng/ml initial result = 60.2 ng/ml, repeat result = 244.9 ng/ml no impact to patient management was 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: 20532819
• Report Number: 1415939-2024-00061
• Device Sequence Number: 17802558
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: (01)00380740001315(17)250325(10)63163FP00
• 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): 11/20/2024

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: 03/25/2025
• Device Catalogue Number: 01L75-25
• Device Lot Number: 63163FP00
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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 Sex: Unknown