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.

• 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: 16717274
• Report Number: 1415939-2023-00025
• Device Sequence Number: 7274496
• 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
• Report Date (Section B): 04/11/2023

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): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/11/2023
• 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: ARC I1000SR MOD, 01L86-01, I1SR56032
• Patient Sex: Unknown