MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT TACROLIMUS REAGENT KIT; ENZYME IMMUNOASSAY, TRACROLIMUS

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	12/08/2020
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.Patient identifier : sid (b)(6).
Event or Problem Description
The customer reported falsely elevated architect tacrolimus results for a patient.The following data was provided (reference range = 2 ¿ 30 ng/ml): on (b)(6) 2020 sid (b)(6) = initial result = > 30.0 ng/ml, dilution 1:2 result = > 60.0 ng/ml, dilution 1:3 result = > 90.0 ng/ml, dilution 1:4 result = >120.0 ng/ml, dilution 1:7 result = 148.2 ng/ml, dilution 1:10 result = 154.1 ng/ml; new blood collection of patient = result = approx.15 ng/ml there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation was performed for observed falsely elevated architect tacrolimus results which included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.The complaint review did not identify an increase in complaint activity related to the falsely elevated results.Trending review determined no trends were identified for the reagent related to the issue.Accuracy testing was performed using an internal tacrolimus panel which mimic patient samples was tested with a retained kit of the reagent lot 14029m800.All specifications were met indicating that the lot is performing acceptably.Device history record review on lot 14029m800 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect tacrolimus reagent lot 14029m800 was identified.

• Brand Name: ARCHITECT TACROLIMUS REAGENT KIT
• Common Device Name: ENZYME IMMUNOASSAY, TRACROLIMUS
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064
• MDR Report Key: 11016890
• Report Number: 1415939-2020-00175
• Device Sequence Number: 4260249
• Product Code: MLM
• UDI-Device Identifier: 00380740001377
• UDI-Public: 00380740001377
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/11/2021

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: 09/10/2021
• Device Model Number: 1L77-25
• Device Catalogue Number: 01L77-25
• Device Lot Number: 14029M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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 I2K PROC MOD, 03M74-01, (B)(4); ARC I2K PROC MOD, 03M74-01, (B)(4)