MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT CYCLOSPORINE

Model Number	1L75-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated architect cyclosporine results for a (b)(6) year old male patient with nephrosis.The patient is taking neoral 25mg twice a day since (b)(6) 2020.The following data was provided: on (b)(6) 2020 result before administering the medication = 96 ng/ml, post one hour >1500 ng/ml, post 2 hours = 1134 ng/ml, post 4 hours = 400 ng/ml.On (b)(6) 2020 result before administering the medication = 105 ng/ml, post one hour = 137 ng/ml, post 2 hours = 357 ng/ml, post 4 hours = 735 ng/ml.The customer believes there should be a peak with the one hour value and will gradually decrease after.The patient received the medication while eating a meal during the last administration.The doctor is inquiring if there is any impact on the results if the administering time is during a meal and if there are any specific meals that give an impact.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records, and accuracy testing.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Accuracy testing was performed to evaluate the performance of reagent lot 10001m800.An internal panel was tested with retained kits of the likely cause reagent lot.Acceptance criteria was met, which indicates acceptable product performance.Labeling was reviewed and found to adequately address the issue of false elevated results.Device history record review was performed on lot 10001m800, which did not show any potential non-conformances, deviations, and no related non conformances.Based on the investigation, no systemic issue or deficiency of the architect cyclosporine reagent lot 10001m800 was identified.

• Brand Name: ARCHITECT CYCLOSPORINE
• Common Device Name: CYCLOSPORINE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 10460145
• Report Number: 1415939-2020-00136
• Device Sequence Number: 2344858
• Product Code: MKW
• UDI-Device Identifier: 00380740001315
• UDI-Public: 00380740001315
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080751
• Number of Events Summarized: 1
• Summary Report (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): 08/28/2020

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: 10/20/2020
• Device Model Number: 1L75-25
• Device Catalogue Number: 01L75-25
• Device Lot Number: 10001M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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: ARCHITECT I2000SR PROCESSING MODULE; ARCHITECT I2000SR PROCESSING MODULE; LIST 03M74-01, SERIAL (B)(6) ; LIST 03M74-01, SERIAL (B)(6)
• Patient Age: 70 YR