MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE REAGENT KIT

Model Number	1L75-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
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.
Event or Problem Description
The customer observed a falsely depressed architect cyclosporine result for one patient a 17 year-old female with aplastic anemia.The results were lower than previous results.The following data was provided: initial result = 139.4 ng/ml retest result = 117.0 ng/ml historical test results = from (b)(6) 2022 = 217.2 ng/ml from (b)(6) 2022 = 187.0 ng/ml no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely decreased architect cyclosporine result 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 testing of the complaint lot number.Trending review determined no related trend for the product.Return testing was not completed, as returns were not available.Accuracy testing was performed using an in-house retained kit of lot 40862fp00.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect cyclosporine reagent, lot number 40862fp00, was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16392964
• Report Number: 1415939-2023-00012
• Device Sequence Number: 6432771
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• 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): 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): 03/26/2023

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: 03/30/2023
• Device Model Number: 1L75-25
• Device Catalogue Number: 01L75-25
• Device Lot Number: 40862FP00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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, ISR64543; ARC I2000SR INST, 03M74-02, ISR64543
• Patient Age: 17 YR
• Patient Sex: Female