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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information.Patient identifier = sid= (b)(6).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 tacrolimus results on one kidney transplant patient.The results provided were: renal transplant performed on (b)(6) and tacrolimus on (b)(6) = around < 10 ng/ml on (b)(6) 2023 sid (b)(6) 1:1=> 30 ng/ml; 1:4=60.30 ng/ml on (b)(6) 2023 sid (b)(6) 1:1= >30 ng/ml; 1:2= >60 ng/ml; 1:3=77.1 ng/ml; 1:4=76.6 ng/ml on (b)(6) 2023 sid (b)(6) 1:1=>30 ng/ml; 1:3=39.60 ng/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, accuracy testing of architect tacrolimus reagent lot 44086fp00.A review of complaints determined that there are no trends for the product for the complaint issue.A review of tickets determined there is as expected complaint activity for lot number 44086fp00.Return testing was not completed as returns were not available.Accuracy testing was performed with a retained kit of lot 44086fp00, and all specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect tacrolimus reagent lot 44086fp00 was identified.
Event or Problem Description
The customer observed falsely elevated architect tacrolimus results on one kidney transplant patient.The results provided were: renal transplant performed on (b)(6) and tacrolimus on (b)(6) = around < 10 ng/ml.On (b)(6) 2023 sid (b)(6) 1:1=> 30 ng/ml; 1:4=60.30 ng/ml.On (b)(6) 2023 sid (b)(6) 1:1= >30 ng/ml; 1:2= >60 ng/ml; 1:3=77.1 ng/ml; 1:4=76.6 ng/ml.On (b)(6) 2023 sid (b)(6) 1:1=>30 ng/ml; 1:3=39.60 ng/ml there was no reported impact to patient management.

• 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
• 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: 16731740
• Report Number: 1415939-2023-00026
• Device Sequence Number: 6663565
• 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
• 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): 05/04/2023

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: 01/13/2024
• Device Model Number: 1L77-25
• Device Catalogue Number: 01L77-25
• Device Lot Number: 44086FP00
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6); (B)(6)
• Patient Sex: Unknown