MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT TACROLIMUS

Model Number	1L77-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2020
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.There was no additional patient information provided by the customer.
Event or Problem Description
The customer reported falsely elevated architect tacrolimus results for one patient.Results provided: initial = 44ng/ml, repeat = 16ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
A review of tickets for lot 10002m800 did not identify an increase in complaint activity or trends related to the falsely elevated results.Return testing was not completed as returns were not available.Accuracy testing was performed with a retained kit of lot 10002m800 and a tacrolimus panel.All acceptance criteria were met, which indicates the product is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect tacrolimus reagent, lot 10002m800.

• Brand Name: ARCHITECT TACROLIMUS
• Common Device Name: TACROLIMUS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 9985476
• Report Number: 1415939-2020-00035
• Device Sequence Number: 3676041
• Product Code: MLM
• UDI-Device Identifier: 00380740001377
• UDI-Public: 00380740001377
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070820
• 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): 05/18/2020

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: 04/24/2021
• Device Model Number: 1L77-25
• Device Catalogue Number: 01L77-25
• Device Lot Number: 10002M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/18/2020
• 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 ANALYZER,; LN 03M74-01, SN (B)(4); ARCHITECT I2000SR ANALYZER,; LN 03M74-01, SN (B)(4)